<figure><img src="image_1.png" /></figure>

### A NEW MANAGEMENT ALGORITHM FOR ESOPHAGEAL PERFORATION, Jon Kiev MD, Amendola F Michael

MD, James Maher MD, Doumit Bouhaidar MD, Bimaljit Sandhu MD, Xian Zhao BS, Virginia Commonwealth University, School of Medicine

**BACKGROUND:** Traditional surgical teaching mandates timely primary repair of esophageal perforations. Despite adequate repair, continued esophageal leakage occurs in about 30% of patients with a large proportion of patients requiring additional procedures. Recently, we have begun managing esophageal leaks using a removable Polyflex (Boston Scientific) esophageal stent.

**METHODS:** A retrospective review was undertaken of 14 patients who had endoscopically placed Polyflex stents for esophageal perforation from 2003 until 2005. 5 secondary and 9 primary esophageal repairs were documented and followed. All patients underwent placement of Polyflex esophageal stents rather than surgical repair.

**RESULTS:** Esophageal stent placement was successful in all patients. No patient required thoracotomy or laparotomy because of stent failure or migration. No patient required surgical repair of his or her esophageal leak following stent deployment. One patient required thoracoscopy for drainage of a previously undrained mediastinal collection. All patients were given and tolerated liquid diets following extubation (1 - 6 days). No contrast extravasation was seen on follow-up esophagrams.

**CONCLUSIONS:** Esophageal perforation is life threatening and requires rapid diagnosis and intervention. Using the Polyflex esophageal stent, a new algorithm has been described that obviates the need for surgery and minimizes extensive intervention with good short-term results.

### DIAGNOSTIC LAPAROSCOPY FOR THE EVALUATION OF OCCULT DIAPHRAGMATIC INJURY FOLLOWING PENETRATING THORACOABDOMINAL TRAUMA, Benjamin S Powell

MD, Louis J Magnotti MD, Christopher W Finnell MD, Thomas J Schroeppl MD, Stephanie A Savage MD, Martin A Croce MD, Timothy C Fabian MD, University of Tennessee Health Science Center. Memphis, TN, USA

**Objectives:** Occult diaphragmatic injury following penetrating thoracoabdominal trauma can be difficult to diagnose.

Radiographic findings are often non-specific or absent.

Undetected injuries may remain clinically silent, only to present later with life-threatening complications associated with diaphragmatic herniation. Diagnostic laparoscopy allows for the evaluation of trauma patients lacking clinical indications for a formal celiotomy. The purpose of this study was to evaluate the incidence of occult diaphragmatic injury and investigate the role of laparoscopy in patients with penetrating thoracoabdominal trauma who lack indications for exploratory celiotomy except the potential for a diaphragmatic injury.

**Methods:** Hemodynamically stable patients with penetrating thoracoabdominal trauma treated at a Level 1 trauma center without indications for celiotomy were evaluated with diagnostic laparoscopy to determine the presence of a diaphragmatic injury.

**Results:** 108 patients were evaluated for penetrating thoracoabdominal injuries (80 stabs and 28 gunshots) over the study period. 22 (20%) diaphragmatic injuries were identified. These were associated with injuries to the spleen (5), stomach (3) and liver (2). There was a greater incidence of hemopneumothorax (HPTX) in patients with diaphragmatic injury (32%) compared to those without injury (20%). 29% of patients with a HPTX had a diaphragmatic injury. However, 18% of patients with a normal chest radiograph were also found to have a diaphragmatic injury.

**Conclusions:** The incidence of diaphragmatic injury associated with penetrating thoracoabdominal trauma is high. Clinical and radiographic findings can be unreliable at detecting occult diaphragmatic injury. Diagnostic laparoscopy provides a vital tool for detecting occult diaphragmatic injury among patients who have no other indications for formal celiotomy.

### MARGINAL ULCERATION AFTER LAPAROSCOPIC GASTRIC BYPASS: AN ANALYSIS OF Predisposing FACTORS IN 260 PATIENTS, Jason J Rasmussen MD, William Fuller MD, Mohamed Ali MD, UC Davis Medical Center

**Background:** Marginal ulceration (MU) after Roux-en-Y gastric bypass (RYGB) is diagnosed in 1-16% of patients. The factors predisposing patients to MU are still unclear.

**Methods:** A total of 260 patients who underwent laparoscopic RYGB were retrospectively reviewed. Data regarding demographics, comorbidities, BMI, H. pylori infection, gastrojejunal (GJ) anastomotic leaks, post operative bleeding, operative time, type of suture material and marginal ulcer formation were collected. Fisher's exact test was used to statistically analyze discrete variables and the student's t-test was used for continuous variables. Statistical significance was set at alpha = 0.05.

**Results:** The overall MU rate was 7%. The various factors hypothesized to affect MU following laparoscopic RYGB are detailed in Table 1. Demographic data (age, gender distribution, BMI) did not differ significantly between patients who developed MU and those who did not (p >0.05). Similarly technical factors (choice of permanent or absorbable suture for the GJ anastomosis, attending as primary surgeon, robotic GJ, operative time, and post-operative hematocrit drop) were not statistically different between the two groups (p >0.05). Finally, the prevalence of comorbidities (diabetes, hypertension, obstructive sleep apnea, musculoskeletal complaints, dislipidemia, GERD and PUD) did not differ significantly between the two groups (p >0.05). However, preoperative H. pylori infection, that was adequately treated, was twice as common among the patients who developed MU compared to those who did not, 32% vs. 12% respectively (p = 0.02). All patients who developed MU had complete resolution of symptoms with PPIs and sucralfate. No reoperations were required for MU.

**Conclusion:** H. pylori may potentiate marginal ulcer formation. We hypothesize that H. pylori damages the mucosal barrier in a way that persists post operatively which may precipitate MU even when the organism was medically eradicated.

<table><thead><tr><th></th><th>No MU</th><th>MU</th><th>P</th><th></th><th>No MU</th><th>MU</th><th>P</th></tr></thead><tbody><tr><td>Age</td><td>42</td><td>40</td><td>NS</td><td>PUD</td><td>3%</td><td>0%</td><td>NS</td></tr><tr><td>% Male</td><td>10%</td><td>11%</td><td>NS</td><td>H. pylori</td><td>12%</td><td>32%</td><td>0.02</td></tr><tr><td>BMI</td><td>44</td><td>45</td><td>NS</td><td>Permanent suture</td><td>53%</td><td>47%</td><td>NS</td></tr><tr><td>Diabetes</td><td>23%</td><td>18%</td><td>NS</td><td>Absorbable suture</td><td>47%</td><td>53%</td><td>NS</td></tr><tr><td>Hypertension</td><td>49%</td><td>37%</td><td>NS</td><td>Attending Primary</td><td>22%</td><td>11%</td><td>NS</td></tr><tr><td>Sleep Apnea</td><td>50%</td><td>37%</td><td>NS</td><td>Robotic</td><td>22%</td><td>5%</td><td>NS</td></tr><tr><td>Musculoskeletal</td><td>79%</td><td>74%</td><td>NS</td><td>OR time (min)</td><td>17%</td><td>17%</td><td>NS</td></tr><tr><td>Dyslipidemia</td><td>42%</td><td>37%</td><td>NS</td><td>Intraop Leak</td><td>9%</td><td>16%</td><td>NS</td></tr><tr><td>GERD</td><td>49%</td><td>53%</td><td>NS</td><td>Hct drop</td><td>7%</td><td>5%</td><td>NS</td></tr></tbody></table>

### IS CONCOMITANT CHOLECYSTECTOMY NECESSARY IN OBESE PATIENTS UNDERGOING LAPAROSCOPIC GASTRIC BYPASS SURGERY?, O Tucker MD, P Fajnwaks MD, T

Escalante-Tattersfield MD, S Szomstein MD, R Rosenthal MD, The Bariatric Institute, Cleveland Clinic Florida, Florida, USA Routine cholecystectomy in patients undergoing laparoscopic gastric bypass is controversial. Morbid obesity is associated with a high prevalence of cholecystopathy and increased risk of cholelithiasis during rapid weight loss. Trans-oral access to the biliary tree is lost after gastric bypass. In the era of open bypass surgery cholecystectomy was performed routinely to avoid a second laparotomy. We performed a retrospective review of a prospectively maintained database of patients undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) from Feb 2000 to Aug 2006. 1696 LRYGBs were performed. All had a preoperative USS to detect gallbladder (GB) pathology. 42 (2.5%) had previous cholecystectomy and were excluded from further analysis. 205 (12%) had GB pathology; cholelithiasis in 199 (83%), sludge in 5 (4%), and a polyp in 1 (0.5%). Cholecystectomy was not indicated for sludge or polyp size <1cm. 123 patients (60%) had a concomitant cholecystectomy at LRYGB, while 82 patients (40%) did not. Of these 120 (97%) were completed laparoscopically with insertion of an additional 5mm operating port.

Concomitant cholecystectomy added a mean operative time of 20 mins (range 15-25). One patient developed a bile leak
<figure><img src="image_2.png" /></figure>

from an accessory biliary radicle requiring diagnostic laparoscopic transgastric ERCP (LTG-ERCP). Of the 82 patients who did not have cholecystectomy 16 (19%) have required subsequent cholecystectomy presenting with biliary colic (n=8), acute cholecystitis (n=6), and choledocholithiasis (n=2). All procedures were completed laparoscopically. 1 patient required transcystic CBD exploration (TCCBDE) with stone retrieval. 89 patients (5.2%) without preoperative GB pathology developed symptomatic cholelithiasis after LRYGB. Of these, 69 (4%) had a cholecystectomy, of which 98.5% were completed laparoscopically. 3 patients presented with gallstone pancreatitis and 2 with obstructive jaundice. 3 required TCCBDE and 1 LTG-ERCP with stone retrieval. 20 patients (1%) did not have further surgery. Another patient who had a cholecystectomy in 1983 presented with choledocholithiasis requiring LTG-ERCP with stone retrieval. In our experience, concomitant cholecystectomy at LRYGB for GB pathology is safe, feasible, and avoids subjecting patients to a second surgical procedure.

**DO RECURRENCES FOLLOWING PARAESOPHAGEAL HERNIA REPAIR MATTER? TEN YEAR FOLLOWUP AFTER LAPAROSCOPIC REPAIR.** Brent C White MD, Louis O Jeansonne MD, Craig B Morgenthal MD, Matthew D Shane MD, Vickie Swafford RN, Leena Khaitan MD, Edward Lin DO, C. Daniel Smith MD, Emory Endosurgery Unit, Emory University School of Medicine.

**Introduction:** Previous studies have demonstrated early hiatal hernia recurrence in as many as 30% of patients following laparoscopic paraesophageal hernia repair. The aim of this study was to determine if patients had recurrent symptoms or need for re-intervention at ten year followup.

**Methods and Procedures:** Consecutive laparoscopic paraesophageal cases performed between 1993 and 1996 were identified in a single-institution prospectively maintained database. Patients were questioned about the presence and severity of symptoms (heartburn, chest pain, regurgitation, dysphagia). Patients were also asked whether they had: 1) been diagnosed with hernia recurrence or 2) undergone repeat surgical intervention.

**Results:** Follow-up was obtained in 43 of 52 total patients (83%). Thirteen patients have died since initial surgery (mean age 79 at time of death). The mean length of follow-up was 11 years (range 10-13 years). The proportion of patients reporting moderate/severe symptoms was less at ten years than preop: heartburn 10% vs. 61% (p<0.001), chest pain 10% vs. 29% (p<0.05), regurgitation 7% vs. 53% (p=0.001), and dysphagia 3% vs. 29% (p=0.002). Three patients (7%) underwent repeat surgical intervention, all of which were due to symptomatic recurrences within the first year. Four more patients (9%) have since been diagnosed with asymptomatic hernia recurrences greater than seven years after surgery; none have required reoperation.

**Conclusions:** Despite previously reported early hiatal hernia recurrence rates of 30%, the majority of patients in this series were asymptomatic and few required further intervention ten years after surgery. These results suggest that late recurrence of a hiatal hernia is unlikely and usually of no clinical significance.

**ROUTINE INTERNAL BILIARY DRAINAGE FOLLOWING LAPAROSCOPIC CHOLEDochOTOMY DOES NOT REDUCE THE RISK OF BILE LEAK.** craig j taylor MD, Laurent Layani MD, Stephen white MD, michael ghusn MD, John Flynn Gold Coast Hospital, Tugun Queensland Australia

**Introduction:** Bile leak following laparoscopic trans-choledochal bile duct exploration for choledocholithiasis is a feared complication with significant and sometimes lethal consequences. Temporary decompression of the biliary system by either external or internal drainage following choledochotomy is widely believed to reduce the risk and severity of post-operative bile leak. Placement of a trans-papillary stent within the bile duct prior to primary duct closure may achieve internal drainage, however the clinical value of this is unproven.

**Methods:** A retrospective comparison of primary duct closure with and without a biliary stent following laparoscopic choledochotomy for choledocholithiasis was performed. Post-operative bile leak was defined as more than 30mls of bile drainage beyond the 3rd postoperative day, re-operation for biliary peritonitis, or radiological drainage of a biloma.

**Results:** 160 consecutive laparoscopic bile duct explorations were performed for choledocholithiasis within a single institution between 2000 and 2005. Of these, 41 laparoscopic choledochotomies were closed primarily following complete clearance, either with (25 patients) or without (16 patients) an internal stent. The 2 groups were well matched for age, preoperative presentation, bile duct diameter, and number of cleared stones. Bile leak occurred in 2/25 cases (8%) in the stent group vs 2/16 cases (12%) in the no-stent group (p=0.64). One death occurred from bile leak in the stent group. Further endoscopic procedures (mostly for stent removal) were required in 100% vs 12% of patients in the stent vs no stent groups (p<0.05). Stent migration occurred in 2 patients (7%). The median length of hospital stay was the same in both groups (5 days).

**Conclusion:** Routine use of biliary stents following choledochotomy does not reduce the risk of bile leak or length of hospital stay but introduces further sources of morbidity and extra procedures.

**FEASIBILITY OF ENDOSCOPIC TRANSGASTRIC DISTAL PANCREATECTOMY (ETDP).** Kai Matthes MD, Tony E Yusuf MD, Mari Mino-Kenudson MD, David W Rattner MD, William R Brugge MD, Gastrointestinal Unit, Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

**BACKGROUND:** Benign pancreatic tumors including cystadenomas and neuroendocrine tumors are often managed with surgical partial pancreatectomy. The aim was to develop an endoscopic minimally-invasive resection technique for removal of localized pancreatic tissue.

**METHODS:** Using an endoscopic transgastric approach, resection of the pancreatic tail was performed in six pigs. All animals were sacrificed after completion of the procedure. The endpoints of this study were technical feasibility and occurrence of complications such as bleeding or perforation.

**RESULTS:** Six Yorkshire breed pigs underwent endoscopy with a double-channel gastroscope. The procedure took on average 77.3 (SD 18.9) minutes. A mean gastric incision of 15.7 (SD 2.0) mm was performed with a needle knife to gain access to the peritoneal cavity. An Endoloop was placed on the distal part of the pancreas. The pancreatic tail was transected (< 3 minutes) using a 27 mm monopolar electrocautery snare with cutting current (see figure). 1-3 hemoclips were placed on the pancreatic stump. 3-4 hemoclips were used to close the stomach incision. The average max. diameter of the pancreatic specimens was 23.3 mm. A second resection was performed in 2 animals (max. diameter 18.7 mm), and a third resection in 1 animal (max. diameter 8.0 mm). There was one complication, an episode of bleeding from a splenic laceration resulting in the loss of 250cc of blood.

**CONCLUSIONS:** For the first time, we demonstrated the technical feasibility of endoscopic transgastric distal pancreatectomy (ETDP). This technique could be considered as a minimally invasive alternative to surgical resection in patients with pancreatic tail tumors.

**PELV-SIM; A NOVEL PELVIC TRAINER DESIGNED TO IMPROVE GYNECOLOGIC LAPAROSCOPIC SUTURING SKILLS.** Deborah Arden MD, Young Bae Kim MD, Daniel B Jones PhD, Christopher S Awtrey MD, Beth Israel Deaconess Medical Center

Training physicians in advanced laparoscopic techniques such as suturing in the live operating room setting is challenging. Many pelvic trainers have been designed to assist physicians develop a basic laparoscopic skill set that can prepare them for the operating room. Many trainers currently focus on abstract tasks and do not attempt to simulate
actual surgical scenarios. The objective of this pelvic trainer is to simulate actual gynecologic surgical tasks requiring suturing skills. The Pelv-sim laparoscopic pelvic suturing trainer is a box model which can be used with a laparoscope and video tower, or by itself. The trainer includes four exercises to teach variations of laparoscopic suturing skills. 1) ligation of an infudibulopelvic ligament, 2) closure of a port-site fascial incision, 3) closure of an open vaginal cuff and 4) transposing an ovary to the pelvic sidewall. We are currently undertaking an IRB approved prospective randomized trial of our model among our resident staff. Initial data gathered demonstrate construct validity.

<figure><img src="image_3.png" /></figure>

The Pelv-sim laparoscopic pelvic suturing trainer is a simple and inexpensive device to simulate gynecologic surgical tasks that require suturing skills. We believe that the Pelv-sim trainer will significantly aide gynecologic surgeons develop proficiency in advanced gynecologic suturing skills.

LAPAROSCOPIC COLECTOMY FOR "BENIGN" COLORECTAL NEOPLASIA: A WORD OF CAUTION, Marc Brozovich

MD,Thomas E Read MD,Salgado Javier MD,William Harb MD,Robert P Akbari MD,James T McCormick DO,Philip F Caushaj MD, Division of Colon and Rectal Surgery, Western Pennsylvania Hospital, Cincal Campus of Temple University School of Medicine. Pittsburgh, PA, USA.

**Purpose:** Endoscopically unresectable “benign” colorectal polyps are considered by some surgeons as ideal cases for their early laparoscopic colectomy experience. Our hypotheses were: (1) a substantial fraction of patients undergoing laparoscopic colectomy for “benign” colorectal neoplasia will have adenocarcinoma on final pathology; and, (2) in our practice, we perform an adequate laparoscopic oncologic resection for “benign” polyps as evidenced by margin status and nodal retrieval.

**Methods:** Data from a consecutive series of patients undergoing laparoscopic colectomy (on an intention to treat basis) for endoscopically unresectable neoplasms with benign preoperative biopsy histology were retrieved from a prospective database and supplemented by chart review. **Results:** The study population consisted of 63 patients (mean age 67, mean BMI 29). 2/63 cases (3%) were converted to laparotomy because of extensive adhesions (n=1) and equipment failure (n=1). Colectomy type: right/transverse (n=49, 78%); left/anterior resection (n=10, 16%); subtotal (n=4, 6%).

Invasive adenocarcinoma was found on histologic analysis of the colectomy specimen in 14/63 (22%), standard error of the proportion 0.052. Staging of the 14 cancers: I (n=6, 43%); II (n=3, 21%); III (4, 29%); IV (1, 7%). Median nodal harvest was 12 (range 5-21) and all resection margins were free of neoplasm.

By univariate analysis, neither dysplasia on endoscopic biopsy nor lesion diameter was predictive of adenocarcinoma, although sample size may be too small to adequately assess these variables.

8/23 (35%) patients with dysplasia on endoscopic biopsy had adenocarcinoma on final pathology vs. 6/40 (15%) with no dysplasia (p=0.114, Fisher's exact test). Mean diameter of benign tumors was 3.2cm (range 0.5-10.0cm) vs. 3.9cm (range 1.5-7.5cm) for adenocarcinomas (p=0.189, t-test).

**Conclusions:** A substantial fraction of endoscopically unresectable colorectal neoplasms with benign histology on initial biopsy will harbor invasive adenocarcinoma, some of advanced stage. This finding supports the practice of performing oncologic resection for all patients with endoscopically unresectable neoplasms of the colorectum. The inexperienced laparoscopic colectomist should approach these cases with caution.

HAND-ASSISTED LAPAROSCOPIC RIGHT HEMICOLECTOMY OFFERS ADVANTAGES OVER OPEN RIGHT HEMICOLECTOMY AND STANDARD LAPAROSCOPIC HEMICOLECTOMY IN PATIENTS WITH COLONIC NEOPLASIA, Jason A Petrofski

MD,Zachary Hollis BA,Christopher R Mantyh MD,Sandyha Lagoo MD,Kirk A Ludwig MD, Duke University Medical Center

**Introduction:** Randomized trials demonstrate that laparoscopic assisted colectomy for neoplasia offers short-term advantages over open colectomy while providing equivalent oncologic outcomes. However, operative times are significantly longer and adoption of laparoscopic techniques for colectomy have been hampered by a long learning curve. Hand-assisted laparoscopic colectomy is an alternative approach that may address these issues. This study compares the outcomes of patients with right sided colonic neoplasia undergoing hand-assisted laparoscopic right hemicolectomy (HAL) to those undergoing standard laparoscopic right hemicolectomy (LRC) and standard open right hemicolectomy (ORC).

**Methods:** A retrospective analysis was performed of 120 consecutive patients undergoing HAL (n=40), LRC (n=40), and ORC (n=40) for right-sided colonic neoplasia utilizing electronic chart review and a prospectively-maintained anesthesia database. Groups were compared by analysis of variance (ANOVA) and chi-square tests, where appropriate.

**Results:** The groups were well matched for age, BMI, previous laparotomies, and co-morbidities. Specimen review showed no between group differences in oncologic parameters (margin status and number of lymph nodes harvested). However, operative times were significantly lower in the HAL and ORC groups (108.4 ± 31.7 and 97.2 ± 37.8) compared to the LRC group (143.6 ± 41.8; p<0.05). In addition, there were no conversions to laparotomy in the HAL group (n=0) compared to four in the LRC group. There were fewer post-operative complications in the HAL and LRC groups (11% & 13%) compared to the ORC group (40%; p<0.05), and length of stay (LOS) in days was less in the HAL and LRC groups (4.7 ± 1.9; 5.1 ± 2.3) when compared to the ORC group (8.2; p<0.05).

**Conclusion:** Both LRC and HAL for neoplasia were associated with a lower complication rate and shorter length of stay than open right colectomy, while maintaining equivalent oncologic clearance as measured by margin length and lymph node harvest. The hand-assisted technique had advantages over the standard laparoscopic technique, however, with a lower conversion rate and shorter operative time and than standard laparoscopic resection, but with a similar LOS.
<figure><img src="image_4.png" /></figure>

<figure><img src="image_5.png" /></figure>
<figure><img src="image_6.png" /></figure>

## S001

**LONG TERM OUTCOMES FOR LAPAROSCOPIC VERSUS OPEN RESECTION OF NON METASTATIC COLORECTAL CANCER**, Muhammad S Mirza, Rob J Longman, Forough Farrokhyar, Jonathon P Sheffield, Robin H Kennedy, Yeovil District Hospital, Yeovil, Somerset UK; McMaster University, Hamilton, Canada

**Background:** Scepticism prevails over the role of minimally invasive surgery in the treatment of colorectal cancer. Long term data on the safety and efficacy of this technique remain scarce. A non-randomised, prospective comparison of laparoscopic colorectal cancer surgery (LS) with open surgery (OS) has been undertaken to evaluate long term survival.

**Methods:** 233 patients with non-metastatic colorectal cancer underwent either laparoscopic (n= 116) or open (n=117), potentially curative resection. Almost all patients between July 1996 and December 2002 were randomised within two consecutive trials, however prior to this a significant proportion of patients received open surgery. The primary end points were overall survival, disease free survival and cumulative disease recurrence. Analysis was by intention to treat.

**Results:** Median follow up was 40 months for LS group and 58 months for OS. No statistically significant difference was found between LS and OS groups regarding overall survival (p=0.603 colon cancer, p=0.841 rectal cancer), disease-free survival (p=0.684 colon cancer, p=0.625 rectal cancer) and overall recurrence (p=0.383 colon cancer, p=0.166 rectal cancer). Cumulative recurrence rate in colon cancer favours OS (p=0.018). In rectal cancer this did not differ between the two treatment modalities (p=0.965). Tumour resection margins and lymph node harvest were similar in the two surgery groups. Perioperative mortality in LS was also no different from OS (p= 0.644 30-day mortality, p= 0.692 in hospital mortality).

**Conclusion:** Long term survival data supports laparoscopic surgery as a safe and effective alternative to conventional surgery for treating potentially curative colorectal cancer. However the higher cumulative recurrence associated with laparoscopic surgery in the colonic cancer group needs further research into its underlying cause.

## S002

**COMPLETELY TRANSVAGINAL CHOLECYSTECTOMY USING MAGNETICALLY ANCHORED INSTRUMENTS**, Daniel J Scott MD, Shou Jiang Tang MD, Raul Fernandez PhD, Richard Bergs MS, Mouza T Goova MD, Ilia Zeltser MD, Jeffrey A Cadeddu MD, University of Texas Southwestern Medical Center, Dallas, Texas. Automation and Robotics Research Institute, University of Texas, Arlington, Texas.

**Introduction:** Natural Orifice Transluminal Endoscopic Surgery (NOTES) is an evolving field and suitable instruments are lacking. The purpose of this study was to perform transvaginal cholecystectomies using instruments incorporated into a Magnetic Anchoring and Guidance System (MAGS).

**Methods:** Non-survival procedures were conducted in pigs (n=3, 32-57kg). Through a vaginotomy created under direct vision, a rigid access port (20mm inner diameter, 30-50cm long) with integrated instrument tethers (electric, mechanical, and pneumatic power supplies) was inserted into the peritoneal cavity and used to maintain a CO2 pneumoperitoneum. MAGS instruments were deployed through the port and held in place on the peritoneal surface using magnetic coupling via an external handheld magnet which was optionally exchanged for an 18ga percutaneous threaded needle anchor; instruments included a tissue retractor (a clip-fixated magnet or flexible graspers) and a cautery dissector. A gastroscope was used for visualization.

**Results:** The first 2 procedures ended prematurely due to instrumentation shortcomings and inadvertent magnetic coupling between instruments; 1 case required a laparoscopic rescue. New instrumentation was developed: 1) a longer access port (50cm) which provided easier deployment of instruments and suitable reach in a smaller animal

(32kg), 2) a more robust cauterizer with improved anchoring strength, a longer, more rigid, pneumatically deployed tip with a forward cam and a rearward positioned anchor with better reach and sufficient torque to allow blunt dissection, and 3) a more versatile tissue retractor with bidirectional dual flexible grasbers maneuvered with a magnetic anchor and then rigidly fixated with a needle anchor which provided excellent cephalad fundus retraction and inferiolateral infundibulum retraction. With these modifications, 100% of the cholecystectomy was completed in the 3rd animal using only a NOTES/MAGS approach. The cystic duct and artery were clipped with EGD clips and the gallbladder was removed using a Roth net. While deployment was successful, retrieval of the tissue retractor was difficult and resulted in a rectal injury.

**Conclusions:** While still under development with more refinements needed, completely transvaginal cholecystectomy using MAGS instruments seems feasible. By offering triangulation and rigidity, MAGS may facilitate a NOTES approach while alleviating shortcomings of a flexible platform.

## S003

**SAFETY, FEASIBILITY AND WEIGHT LOSS AFTER TRANSORAL GASTROPLASTY (TOGA): FIRST HUMAN MULTICENTER STUDY**, J Devière MD, G Ojeda Valdes MD, L Cuevas Herrera MD, J Closset MD, O Le Moine MD, P Eisendrath MD, C Moreno MD, S Dugardeyn MD, M Barea MD, S Scott MD, R de la Torre MD, S Edmundowicz MD,

(1) Gastroenterology, ULB - Hôpital Erasme, Brussels, Belgium, (2) Surgery, Hopital Regional 1st de Octubre, Mexico City, Mexico, (3) Surgery, University of Missouri, Columbia, Missouri, USA (4) Gastroenterology, Washington University, St. Louis, Missouri,

**OBJECTIVE:** To evaluate the safety and feasibility in human subjects of a new transoral restrictive procedure for treatment of obesity.

**METHODS:** The protocol was approved by the IRBs of both centers, and all patients underwent informed consent. Patients met established inclusion criteria for bariatric surgery. The TOGa System (Satiety Inc, Palo Alto, CA), a set of transoral endoscopically-guided staplers, was used to create a stapled restrictive pouch along the lesser curve of the stomach, similar to other restrictive pouches. Patients were hospitalized overnight for observation and underwent barium UGI the next morning. Post procedure, all patients were placed on a liquid diet for one month and asked to begin an exercise program. Follow-up was completed at 1 week and 1, 3 and 6 months.

**RESULTS:** Twenty one patients were enrolled (17 female, age 43 (22-57), BMI 43.3 (35-53)). Device introduction was completed safely in all patients. There were no complications or serious AEs. Procedure-related AEs were self-limiting and all resolved within 5 days (nausea, vomiting, pain, dysphagia, pharyngitis), with the exception of one case of mild temporomandibular dysfunction that lasted 7 days, and one case of persistent post-prandial fullness. At most recent endoscopy (3 or 6 mos), all patients had persistent full or partial stapled sleeves. Patients lost an average 17.5 pounds at 1 month and 24.7 pounds at three months post-treatment (EWL of 14.9% and 20.5%, respectively). At six months, average weight loss was 31.1 pounds and EWL was 24.9% for patients followed-up to date (n=6).

**CONCLUSIONS:** There is great interest in new procedures for morbid obesity that offer lower morbidity than current options. Early experience with the TOGa procedure indicates that this transoral approach may be safe and feasible. Further experience with the device and technique should improve anatomic and functional outcomes in the future. Additional studies are underway.

## S004

**POSTOPERATIVE ESOPHAGEAL PHYSIOLOGY STUDIES MAY HELP TO PREDICT LONG TERM SYMPTOMS FOLLOWING LAPAROSCOPIC NISSEN FUNDOPLICATION**, A P Boddy BA, S Mehta BA, J Bennett BA, D Mahon MD, M Rhodes MD, Dept of Surgery, Norfolk and Norwich University Hospital,
<figure><img src="image_7.png" /></figure>

Norwich, UK

**Background:** Laparoscopic Nissen fundoplication is an established treatment for gastroesophageal reflux disease (GERD). Postoperative improvement in esophageal physiology can be indicative of successful surgery, but the degree to which it correlates with symptom control remains questionable. We have performed this study to assess the utility of postoperative esophageal physiology studies in predicting long term symptomatic outcome.

**Methods:** Between August 1997 and August 2003 145 patients with symptomatic GERD underwent laparoscopic Nissen fundoplication as part of a randomised trial (91 were initially randomised to surgery and 54 crossed over at a later date). Four months after surgery patients were invited to have postoperative esophageal physiology studies. In November 2005 a postal questionnaire was sent to all patients in order to assess reflux symptomatology (Demeester symptom score).

**Results:** Completed symptom questionnaires were returned by 108 patients (74%) at a median time of 5.7 years postoperatively. Of these patients, 78 (72%) had undergone postoperative esophageal physiology studies. Linear regression of postoperative manometry data showed a significant correlation between difference in neospihcter above or below 17 mmHg (the median pressure) and scores for heartburn (p=0.03), dysphagia (p=0.02), regurgitation (p=0.01) and total symptom score (p=0.002). Linear regression models did not reveal a statistically significant correlation between results of esophageal pH studies and scores of heartburn, but when patients were divided into quartiles dependent on their physiology study results, analysis of variance did reveal a significant effect (p=0.04).

**Conclusion:** Postoperative physiology studies, particularly manometry, may be predictive of long term symptoms following laparoscopic Nissen fundoplication.

## S005

**IMPEDANCE PREDICTS RESPONSE TO NISSEN FUNDOPILATION IN PATIENTS WITH POOR RESPONSE OF HEART-BURN TO PPIS**, Brant K Oelschlager MD, Valeria Martin MD, Federico Cuenca-Abente MD, Carlos A Pellegrini MD, The University of Washington

Patients with GERD whose heartburn (HB) responds poorly to proton pump inhibitors (PPIs) are considered poor candidates for Nissen fundoplication (NF). HB can be due to persistent acid or non-acid (pH>4) reflux, both of which can be detected by pH/Impedance monitoring (PH-IMP). We performed a prospective trial to determine the utility of PH-IMP in predicting which patients are good candidates for NF.

**Methods:** All patients (n=240) evaluated for NF in a 24 month period (2004-05) were evaluated on and off therapy in which HB was graded with a 10 point symptom severity score (SSS). Only patients with poor initial response of HB to bid PPIs (SSS on meds > 5, and a difference in SSS [off meds - on meds] <4) were invited to participate (n=20), and 8 patients enrolled. Each had standard pH monitoring off meds, PH-IMP on bid PPIs, and NF followed 6 months later with a SSS and PH-IMP. Reflux episodes detected by impedance were divided into acid (pH<4) and nonacid (pH>4). We defined normal reflux as a DeMeester score <14.7 (pH) and less than 50 episodes of reflux detected with impedance (IMP).

**Results:**

<table><thead><tr><th></th><th>HB SSS</th><th>DeMeester Score</th><th># Reflux Episodes (nonacid) - IMP</th><th># Abnormal studies - IMP</th></tr></thead><tbody><tr><td>Pre-op off PPIs</td><td>8.8 ± 1.2</td><td>38.3 ± 23.5</td><td>N/A</td><td>N/A</td></tr><tr><td>Pre-op On PPIs</td><td>5.8 ± 1.3*</td><td>19.2 ± 16.6</td><td>74 (46)</td><td>7 (88%)</td></tr><tr><td>Post-op off PPIs</td><td>1.3 ± 2.2†</td><td>2.5 ± 2.9*</td><td>5 (2)†</td><td>0†</td></tr></tbody></table>

Six patients experienced complete, and 1 near complete (SSS 10 to 3), resolution of HB after NF. Of these 7, 5 had abnormal PH and all had abnormal IMP. The other patient had minimal improvement of HB (SSS 9 to 6). This patient had normal IMP and PH on PPIs before NF.

**Conclusions:** Patients with GERD whose HB does not respond to PPIs AND have abnormal PH/IMP on PPIs respond well to NF. The addition of impedance to pH monitoring may predict which patients who don't respond to PPIs will respond to NF.

## S006

**WHO WILL FAIL LAPAROSCOPIC NISSEN FUNDOPILATION? PREOPERATIVE PREDICTION OF LONG TERM OUTCOMES**, Craig B Morgenthal MD, Matthew D Shane MD, Edward Lin DO, C. Daniel Smith MD, Emory Endosurgery Unit, Emory University School of Medicine, Atlanta, Georgia, USA

**INTRODUCTION:** A small but significant percentage of patients are considered failures after laparoscopic Nissen fundoplication (LNF). We sought to identify preoperative predictors of failure in a cohort of patients who underwent LNF more than 10 years ago.

**METHODS:** Of 312 consecutive patients undergoing primary LNF between 1992 and 1995, recent follow-up was obtained from 166 patients at a mean of 11.0 ± 1.2 years. Eight patients known to have undergone reoperation were lost to follow-up but are included in this analysis. Failure is broadly defined as any reoperation, lack of satisfaction, or any severe symptoms at follow-up. Potential preop predictors evaluated included sex, age, absolute weight, BMI, response to acid reducing medications (ARM), psychiatric history, prior abdominal surgery, typical versus atypical symptoms, hiatal hernia, Barrett's esophagus, benign stricture, dilatation, manometry, and esophageal pH. Potential preop predictors underwent univariate analysis using logistic regression for continuous variables and Chi-square for categorical variables.

**RESULTS:** Of 174 known outcomes, 131 were classified as successful (75.3%), while 43 were failures (24.7%): 26 reoperations, 13 unsatisfied, and 13 with severe symptoms. Response and lack of response to ARM were associated with 77.1% and 56.0% success rates respectively (P = 0.035, odds ratio 2.6). Eighty four percent of patients with typical symptoms were categorized as successful, compared to only 41% with atypical symptoms (P < 0.001, odds ratio 7.8). Variables that did not achieve statistical significance include preop BMI (p = 0.60), psychiatric history (p = 0.06), and size of hiatal hernia (p = 0.55).

**CONCLUSION:** In a cohort with eleven years follow-up after LNF, factors predictive of successful long term outcome include preoperative response to ARM and typical symptoms. Patients with atypical symptoms or lack of response to ARM should be informed of their higher risk of failure.

## S007

**MEASURES OF HEALTH RELATED QUALITY OF LIFE FOR ACHALASIA**, Julie L Harnish MSc, David R Urbach MD, Gail E Darling MD, Nicholas E Diamant MD, Paul P Kortan MD, George A Tomlinson PhD, Wayne Deitel MD, Audrey Laporte PhD, University Health Network, St. Michael's Hospital, University of Toronto, Toronto, ON Canada

**Introduction:** Various instruments may be used to measure health-related quality of life in patients with achalasia.

**Methods:** We administered 4 patient-centered measures used for evaluation of achalasia severity (an Achalasia Severity Questionnaire we developed previously, an Achalasia Symptom Checklist, the Gastrointestinal Quality of Life Index [GIQLI] and the MOS 36-item Short Form Survey [SF-36]) to 17 subjects enrolled in a randomized controlled trial comparing pneumatic dilatation and laparoscopic Heller myotomy. The instruments were administered after randomization, and prior to treatment. We estimated correlations between the different measures.

**Results:** 17 patients (9 male, 8 female) were studied, 8 of whom were assigned to pneumatic dilatation and 9 of whom were assigned to laparoscopic myotomy. The average age of patients was 46 (range 25-69, SD 14). Baseline scores demonstrated a substantial burden of impairment. The mean (standard deviation [SD]) score on the Achalasia Severity Measure (which ranges from 0 [best] to 100

<footnote>* Significant difference compare to Pre-op off meds (p<0.05)</footnote>

<footnote>† Significant difference compare to Pre-op on meds (p<0.05)</footnote>
[worst]) was 63.9 (13.7). The mean (SD) Symptom Checklist score (ranges from 0 [best] to 36 [worst]) was 24.1 (6.4). The mean (SD) GIQLI (ranges from 0 [worst] to 144 [best]) was 72.17 (17.9). The SF-36 mean (SD) score (ranges from 0 [worst] to 100 [best]) was 49.7 (21.9) The Achalasia Severity Measure correlated highly with the GIQLI (r=-.61, p=.01), and the Symptom Checklist (r=.66, p=.004), but not with the SF-36 (r=-.236, p=.36), which is a generic health related quality of life measure.

**Conclusion:** Among subjects recruited to a randomized controlled trial of achalasia treatment, there was impairment in both generic and disease-specific quality of life. Scores on disease specific measures correlated with each other, but not with measures of generic quality of life.

## S008

### LAPAROSCOPIC HELLER MYOTOMY FOR ACHALASIA:

**RESULTS AFTER TEN-YEARS**, Alexander Rosemury MD, Sarah M Cowgill MD, Sharona Ross MD, Desiree Villadolid MPH, Robert Boyle, Sam Al-Saadi MD, Michael Albrink MD, University of South Florida, College of Medicine

**Introduction:** Laparoscopic Heller myotomy was first undertaken in the early 1990's and appreciable numbers of patients with ten-year follow-up are now available. This study was undertaken to determine long-term outcomes after laparoscopic Heller myotomy to treat achalasia.

**Methods:** 337 patients have undergone laparoscopic Heller myotomy since 1992; 47 patients, 55% male, of mean age 49 years (range 18 to 85 years) underwent myotomy more than 10 years ago and have been followed through a prospectively maintained registry. Among many symptoms, patients scored dysphagia, chest pain, vomiting, regurgitation, choking, and heartburn, before and after myotomy using a Likert scale, ranging from 0 (never/not bothersome) to 10 (always/very bothersome). Symptom scores before vs. after myotomy were analyzed using a Wilcoxon matched-pairs test. Data is reported as median, mean ± SD.

**Results:** Length of stay was 2 days, 3 ± 8.6 days (range 1 to 60 days). Notable complications were infrequent after myotomy (1 acute renal failure, 1 enterotomy). There were no perioperative deaths. 1 patient required a "redo" myotomy after 5 years because of recurrence of symptoms. 33 (70%) patients are still alive: causes of death after discharge were unrelated to myotomy and included pneumonia, congested heart failure, and myocardial infarction. The frequency and severity scores of dysphagia, chest pain, vomiting, regurgitation, choking, and heartburn all decreased significantly after laparoscopic Heller myotomy (p<0.0001 for all). For example, severity of dysphagia decreased from 10, 9 ± 1.2 before myotomy to 1, 2 ± 2.6 (p<0.0001) ten years after myotomy.

**Conclusions:** Laparoscopic Heller myotomy can be undertaken with few complications. Laparoscopic Heller myotomy significantly decreases the frequency and severity symptoms of achalasia without promoting heartburn. Symptoms of achalasia are durably ameliorated by laparoscopic Heller myotomy with long-term follow-up, thereby promoting application of laparoscopic Heller myotomy.

## S009

ESOPHAGEAL ACID CLEARANCE PHYSIOLOGY IS ALTERED AFTER NISSEN-COLLIS GASTROPLASTY, Alfonso Torquati MD, Yassar Youssef MD, Rami Lutfi MD, Joan Kaiser MSc, William Richards MD, Vanderbilt University

Nissen-Collis Gastroplasty (NCG) is an effective treatment for short esophagus but sometime is associated with abnormal postoperative esophageal acid exposure. Our study was designed to test the hypothesis that NCG prevents gastric reflux and the pathologic distal esophagus acid exposure is due to prolonged acid clearance in the neoesophagus.

**Methods:** The IRB approved study supported by a SAGES research grant was conducted at Vanderbilt University. The study enrolled 11 normal subjects, 10 patients s/p Nissen fundoplication and 9 patients s/p NCG. All the participants were age and gender matched. All subjects were studied via manometry, acid clearance test and 24-h pH study. The clearance test was performed according to Helm (NJEM,

1984). A 15 ml bolus of 0.1 N HCl (pH 1.2) was rapidly infused (x4) 15 cm proximal to the LES, followed by dry swallows every 30 seconds, until esophageal pH rose above 4.

**Results:** All the subjects had normal esophageal peristalsis and distal amplitudes. As shown in Figure 1, the acid clearance time was significantly higher in NCG (P=0.001 vs Nissen and Normals).

<figure><img src="image_8.png" /><figcaption>Figure 1. Esophageal chemical clearance time after infusion of 15 ml acid bolus</figcaption></figure>

Pathologic esophageal acid exposure occurred in 1 of 10 Nissen patients (10%) and in 2 of 9 patients (22%) after NCG (P=NS). Median distal esophageal acid exposure time was similar in the 2 groups (NCG= 2.5%, Nissen=1.2%, P=NS). In the NCG group, symptomatic reflux episodes were more common (P=0.05) and were significantly associated with longer acid clearance time (P=0.001)

**Conclusion:** NCG is a good barrier against acid gastric reflux but increases the prevalence of symptomatic reflux episodes secondary to delayed esophageal acid clearance.

## S010

RANDOMIZED CLINICAL TRIAL OF LAPAROSCOPIC HIATOPLASTY WITH TOTAL FUNDOPLICATION AND GASTRIC FUNDUS MOBILIZATION WITH OR WITHOUT ROUTINE DIVISION OF SHORT GASTRIC VESSELS, Jose F Farah PhD, Alberto Goldenberg PhD, Vladimir Schraibman MD, Julio C Martinez PhD, Jaques Matone MD, Jose C Del Grande PhD, Federal University of Sao Paulo and Hospital Servidor Publico Estadual

**Introduction:** Gastric fundus mobilization may play an important role in the outcome after total fundoplication. Routine division of short gastric vessels (SGV) is still a controversial issue, even in laparoscopic era.

**Aim:** Evaluate short and long term results after fundoplication procedure, concerning the division of SGV.

**Methods:** A prospective randomization of 90 patients with indication for hiatoplasty and total fundoplication was performed. They were divided into two groups: no SGV division (Group A, n= 46) and with SGV division (Group B, n=44). Early outcome, clinical follow up and a 5-year routine endoscopic evaluation were analyzed.

**Results:** Both groups were similar regarding preoperative parameters and severity of gastroesophageal reflux disease (GERD). No difference in morbidity was observed during hospital stay. Nevertheless, the median operating time was 80,2 minutes in Group A and 94,1 minutes (p=0,0045) in Group B. Transitory dysphagia during the first year was significantly lower in Group B (56,5% versus 29,5%, p=0,012). However, long term clinical outcome was similar in both groups (clinical symptoms of GERD, persistent dysphagia and reoperations). The 5-year endoscopic follow-up evaluation revealed that anatomic failure of fundoplication was significantly higher in Group B (with division SGV) when compared to Group A (28,5% and 9,1%, p=0,027).

**Conclusion:** Mobilization of gastric fundus without routine division SGV is an alternative for routine division, in total fundoplication procedure, and related with less anatomic failure on long follow-up.

## S011

COMPLEX LAPAROSCOPIC SURGERY IN PATIENTS WITH END-STAGE LUNG DISEASE, Abraham Lebenthal MD, Philip M Hartigan MD, Heather Edenfield MS, Richard J Gilbert MD, Philip A Linden MD, Raphael Bueno MD, Brigham and Women's Hospital

**Background:** Severe lung disease is considered by most to be a contraindication to laparoscopic surgery, partly due to concerns over impaired gas exchange, hypercarbia and CO2
<figure><img src="image_9.png" /></figure>

pneumo-peritoneum. We evaluated the respiratory performance during the operative and immediate postoperative period in patients with end stage lung disease undergoing laparoscopic fundoplication.

**Methods and Procedures:** We performed 566 consecutive elective laparoscopic anti-reflux procedures between January of 1999, and August of 2006 for patients with documented GERD. Of these, 24 had end stage lung disease sufficient to meet UNOS listing criteria for lung transplantation at the time of their laparoscopy. A retrospective chart review was performed to examine all perioperative and postoperative respiratory events including operative time, arterial blood gas (ABG) determination and need for prolonged intubation.

**Results:** The average time from induction to extubation was 220 minutes (range 158-390 minutes) with an average operative time of 179 minutes (range 110-354 minutes). All 24 patients were extubated, at the completion of surgery and remained extubated for the duration of their hospitalization. None of the patients required admission to the ICU. Fourteen of 24 (58%) patients had ABG during surgery with a mean PCO2 of 49.4 mmHg (range 32-82 mmHg). The average PCO2 for 18 of the patients (75%) who had ABG during the immediate postoperative period was 48.3 mmHg, and at 24 hour it was 48.6 mmHg.

**Conclusion:** In the setting of a tertiary academic center with thoracic anesthesia and surgical expertise it is possible to safely perform laparoscopic surgery in patients with advanced lung disease. In this setting, hypercarbia proved not to be a significant outcome of laparoscopic surgery. Intra-operative patient management including: adequate pain control with thoracic epidural, careful attention and fine tuning of ventilation parameters and the combination of an experienced thoracic anesthesiologist and advanced laparoscopic surgeon can allow the safe management of patients with end stage lung disease.

## S012

**ENDOSCOPIC & SYMPTOMATIC ASSESSMENT OF ANASTOMOTIC STRICTURES FOLLOWING ESOPHAGECTOMY & CERVICAL ESOPHAGOGASTROSTOMY: INCIDENCE & PRESENTATION,** Valerie A Williams MD, Thomas J Watson MD, Svetlana Zhovtis BA, Fernando Herbella MD, Oliver Gellersen MD, Daniel Raymond MD, Carolyn Jones MD, Jeffrey H Peters MD, University of Rochester, Rochester, NY.

Benign anastomotic strictures following esophagectomy and cervical esophagogastric anastomosis are common, and predisposing factors for their development are unclear. The purpose of this study was to evaluate the incidence and characteristics of cervical anastomotic strictures following esophagectomy.

**METHODS:** The study population consisted of 41 patients undergoing esophagectomy with gastric interposition and cervical anastomosis. Patients were followed prospectively and any complaint of post-operative dysphagia was investigated with upper endoscopy. Strictures were assigned to balloon or bougie dilation as part of a prospective randomized trial. Post-operative dysphagia was assigned a standardized severity score and stricture diameter pre-dilation was classified as minimal (>12mm), mild (9-12mm), moderate (5-8mm), or severe (<5mm). Outcome measures included the incidence and severity of symptomatic anastomotic strictures, time to first dilation, and influence of anastomotic technique on stricture occurrence.

**RESULTS:** Twenty-five of the 41 (60.9%) patients underwent endoscopy and dilation. Median time to presentation was 2.4 mos (min 27d, max 11mos). Most patients (65%) with stricture complained of dysphagia with every meal. The majority (92%) of strictures were mild to moderate (5-12mm) and there was no correlation between dysphagia frequency and stricture size. Tolerance of an unrestricted diet decreased with increasing stricture severity. A total of 75 dilations were performed without complication. There was a trend towards a higher stricture rate following hand-sewn anastomoses as compared to combined stapled and hand-sewn anastomoses (78.6% v 51.8%, p=0.091).

**CONCLUSIONS:** The development benign anastomotic strictures following esophagectomy with cervical esophagogastrotomy is common. Most patients will present with stricture within the first few months following surgery. Both endoscopic balloon and bougie dilation of these strictures is safe. A combined hand-sewn and stapled anastomosis may decrease the risk of stricture formation. Interventions to decrease stricture development such as post-operative proton-pump inhibitor therapy should be evaluated.

## S013

**MINIMALLY INVASIVE VIDEO-ASSISTED THYROIDECTOMY AND CONVENTIONAL THYROIDECTOMY: A PROSPECTIVE RANDOMIZED STUDY,** Istvan Gal PhD, Zoltan Szabo PhD, A Balint MD, Gy Bolgar MD, Department of Surgery Bugat Pal Univ Hosp, Gyöngyös Hungary, MOET Institute San Francisco, CA USA

Since the first description of technique of minimally invasive totally gasless video-assisted thyroidectomy in 1998, only a few prospective randomized study evaluated advantages of this minimally invasive procedure.

Thirty patients undergoing surgery for either thyroid nodule or diffuse thyroid disease with hyperthyroidism were allotted to one of these procedures, minimally invasive video-assisted thyroidectomy (MIVAT) or conventional thyroidectomy (CT). Exclusion criteria were nodules greater than 35mm, thyroid lobe volume greater than 20ml, presence of thyroiditis and presence of previous neck irradiation or surgery. Operative time, postoperative complications and cosmetic results were evaluated.

MIVAT group included 15 patients and the CT group 15 patients. No significant differences were signed between the two groups in terms of age, sex and indication for operation. Operative time was 68.53±18 minutes for MIVAT and 43.3±14minutes for CT(p value less than 0.05). No postoperative complications were detected in each group. Cosmetic results evaluated by verbal response scale and numeric scale were for MIVAT 3.7± 0.2, 7.9±1.2 and for CT 2.3±0.7,4.9±1.3 respectively. The difference was significant in favour for MIVAT( p value less than 0.05 and 0.05 respective-ly).

**Conclusion:** Although the conventional thyroidectomy has less operative time, the minimally invasive video-assisted thyroidectomy offers advantages to selected patients in terms of very good or excellent cosmetic results while the postoperative complications are comparable.

## S014

**VIDEOENDOSCOPIC NECK SURGERY- AN EXPERIENCE OF 43 CASES,** Pradeep Chowbey MS, Chairman - Minimal Access & Bariatric Surgery Centre, Sir Ganga Ram Hospital, New Delhi (India)

Minimal access surgery has expanded in technical expertise, instrumentation and surgical stature since its inception over a decade ago. Its application beyond preformed cavities has also taken firm roots as experience with retroperitoneal and groin hernia surgery have met with tremendous success. The neck is another region where well defined tissue planes, with minimal vascular interference provide an ideal site for performing surgery by this technique. Benign thyroid nodules and parathyroid adenomas are the commonest indications for endoscopic neck exploration. Other indication include carotid body tumor, cervical discectomies and tuberculosis of cervical spine. The pretracheal space deep to the strap muscles forms the working space. The tracheal rings mark the midline and the carotid sheath defines the lateral limit of dissection. Since Jan'99 we have attempted a minimal access approach in 43 patients (25 patients with thyroid nodules and 18 patients with parathyroid pathologies). In 40 patients the approach involved CO2 insufflation and in 3 patients (all parathyroid adenomas) a Micolli's approach was adopted. One patient required conversion to a conventional neck exploration due to non-identification of the parathyroid adenoma. In another patient a completion thyroidectomy was performed conventionally when histopathology showed a concomitant multicenteric papil-
lary carcinoma. Basic surgical principles remained the same as for conventional surgery. Identification of anatomical structures was better due to magnification. Dissection was performed with both monopolar cautery and harmonic scalpel. External palpation helped in dissection and to control bleeding. Disadvantages included early fogging and inability to use suction due to loss of working space. This was overcome to a certain extent by placing the access ports below the clavicle which resulted in increasing the working space. Recovery was rapid and cosmesis highly appreciated by the patient.

## S015

**TRANSAXILLARY ENDOSCOPIC PARATHYROIDECTOMY: A PRACTICAL ALTERNATIVE TO THE OPEN APPROACH,**
Qammar Rashid MD, Titus Duncan MD, Ijeoma Ejeh Ejeh MD, Fredne Speights MD, Department of Surgery: Morehouse School of Medicine

**Introduction:** Transaxillary endoscopic parathyroidectomy is a safe and feasible procedure for patients with benign parathyroid disease. Minimally invasive surgery has well documented advantages of cosmesis, better visualization, and postoperative pain management. We present the use of an endoscopic technique to access the parathyroid gland from a remote transaxillary site. Endoscopic neck procedures may be approached in a direct or indirect fashion. A direct approach is an anterior approach that allows visualization of anatomy that is similar to the open technique. The indirect approach is from a remote site such as the axilla, and visualization is skewed and not that typically seen in the open approach. The indirect approach requires significant invasion of natural tissue architecture to advance to the target area. It does, however, avoid visible scarring within the neck region that may possibly improve the overall cosmetic outcome. The resulting incisions are small and well hidden in the axilla, and not visible when the patient has the arm in a natural anatomic position.

**Materials and Methods:** We performed a transaxillary approach to the parathyroid gland for 11 patients presenting with primary hyperparathyroidism and diagnosed with unilateral parathyroid adenoma(s) over a 2 year period (July 2004 - July 2006). There were 2 men and 9 women. The average age of the patients in this series was 53 (range 34 - 75).

**Results:** The final pathology of each patient's gland was benign parathyroid adenoma with an average weight of 1550 mg (range 100 mg - 2400mg). Ten patients had a single hyperplastic parathyroid lesion while one patient had two ipsilateral hyperplastic glands. Each patient had documented elevated calcium and PTH levels preoperatively with symptoms characteristic for clinical hyperparathyroid disease. All PTH levels normalized. There were no postoperative complications.

**Conclusion:** Garnier et al reported the first endoscopic parathyroidectomy, and Takami et al have since reported the transaxillary endoscopic approach to the thyroid and parathyroid glands. The advantages of this approach include superior visualization of critical anatomy of the neck, and superior cosmetic outcome with no visible scar in the neck region. We conclude that the transaxillary approach to the parathyroid gland is a safe, and feasible alternative to the open technique of parathyroidectomy for single or unilateral glandular disease.

## S016

**AXILLARY SENTINEAL LYMPH NODE BIOPSY BY ENDOSCOPIC PROCEDURE,** Motoo Yamagata MD, Kazuo Sato MD, Yukie Morishita, Minoru Matsuda MD, Tadatoshi Takayama, Department of Surgery, Nihon University Endoscopic breast conserving therapy improved esthetic factors of breast conserving surgery by reducing the size and changing the position of surgical wounds as skin sparing surgery. It is not minimally invasive. SLNB minimize invasion of breast conserving surgery. Endoscopic sentinel lymph node biopsy was showed same detection rate by dye -injection method except radioisotope.

These method was safety and feasible. endoscopic breast conserving surgery.

**Method:** F Endoscopic axillary sentinel lymphnode(SLN) biopsy consist of 4 step,
1st step: Dye (we usually use indigo carmine) was injected at the point close to tumor. 2nd. step is the method for making cavity in axilla. VISIPORT is inserted into axillary space for introduce dissecting balloon to the proper layer.
3rd. step: dissecting balloon was inserted into axillary space and inflated for making working space. Stained SLNB was detected by endoscopic observation.

Stained lymph nodes were dissected by open method or endoscopic method under pneumo-axilla (8mmHgCO2).
**Results:** SLNB was performed in 116cases Detection rate is 96.9% "i31/32". True positive rate 93.7% "A@Average OP time@136min.@Average Bleeding@63.5, ‡. Hospital stay after OP@4days@Cosmetic finding@after operation@was@better than normal procedure. @Because operation scar of SLNB was very small. And Axillary function was preserved except rehabilitation. @Minimally invasive breast surgery was not improved esthetic factors of breast surgery but also preserving function except rehabilitation. the patients with early breast cancer will take more benefits by using this technique.

## S017

**ENDOSCOPIC EXCISION OF FIBROADENOMA BREAST,** B B Agarwal, S Agarwal, M K Gupta, V R Saggar, K C Mahajan, Sir Ganga Ram Hospital & Lady Hardinge Medical College, N.Delhi, India

**Objectives:** To perform Endoscopic excision of fibroadenoma, breast, safely and aesthetically.

**Methods & Procedures:** Circumareoler incision is universally recognized as a good & cosmetic approach for fibroadenoma excision. Surgery leaves not only physical but psychological scars as well, which seems more relevant to breast surgery. Possibility of some structural & physiological disruption of the nipple-areola complex is a potential concern. We excised the fibroadenomas of all sizes from 2-5cms. Endoscopically by placing the trocars along or just behind the anterior axillary fold. Usually two working ports & a camera port (10mm) are required. However in case of a large or less mobile fibroadenoma a single working port was also sufficient. The firoadenoma once completely dissected was extracted through the 10mm. port, while a 5mm. telescope was put in the working port. Perfect haemostasis was ensured & confirmed under vision. A compression bandage for 72hrs. was applied to the area of excised lump

**Results:** There was no failure or need to convert in 12 consecutive unselected patients of fibroadenomas presenting in all quadrants of the breast. There was no bleeding or collection. Port sites were not visible in frontal view, there were no scars over the breast and port site scars remained hidden in the anterior axillary fold.

The ladies expressed pleasure and appreciation for their breast exterior not subjected to knife.

**Conclusion:** Endoscopic excision of benign breast lumps such as fibroadenoma is possible, safe, aesthetic and is appreciated by ladies.

## S018

**LAPAROSCOPIC BILATERAL ADRENALECTOMY: RESULTS OF 30 CONSECUTIVE CASES,** Mark C Takata MD, Quan-Yang Duh MD, Department of Surgery, University of California San Francisco

**Background:** Laparoscopic adrenalectomy has become the standard treatment for surgical diseases of the adrenal gland. Most patients requiring bilateral adrenalectomy have adrenocorticotropin hormone (ACTH) dependent Cushing's syndrome. Some of these patients are severely debilitated from the chronic effects of cortisol overproduction.

**Objective:** To analyze the safety, efficacy, and outcomes of our experience with laparoscopic bilateral adrenalectomy (LBA).

**Design:** Retrospective review.

**Setting:** University tertiary referral center.
<figure><img src="image_10.png" /></figure>

**Patients:** Thirty consecutive patients underwent simultaneous LBA utilizing a transperitoneal approach.

**Methods:** We analyzed patient records to obtain demographics, disease etiology, clinical course, surgical approach, operative information, postoperative complications (30 days), and length of hospitalization.

**Results:** There were 22 female and eight male patients with a mean age of 44 years. Disease etiology consisted of refractory Cushing's disease (N=16), ectopic ACTH (N=9), and bilateral pheochromocytoma (N=5). ACTH dependent Cushing's syndrome was present in 25 of 30 patients (83%) and a median of 23 months (range 2 to 348 months) elapsed between onset of symptoms and adrenalectomy. LBA was completed in all 30 patients with no intraoperative complications. The median operative time was 270 minutes (range 180 - 480 minutes). The median estimated blood loss was 50 mL. Seven complications (pneumonia, Addisonian crisis, disseminated intravascular coagulation, wound infection, hyponatremia, and two urinary tract infections) occurred in four (13%) patients. The mean length of postoperative hospitalization for all patients was 3.5 days (range 1 to 12 days). Seven patients had a preoperative hospitalization with a mean of 7.1 days (range 1 to 20 days) and a mean postoperative hospitalization with a mean of 5.0 days (range 2 to 12 days). If no preoperative hospitalization was required the mean length of hospitalization was 3.0 days (range 1 to 7 days). Preoperative hospitalization did not predict postoperative complication. All patients received postoperative steroid replacement and appropriate follow-up with an endocrinologist.

**Conclusion:** LBA is safe and effective in this high risk patient population. Although patients should be monitored closely in the postoperative period, most patients are discharged with steroid replacement in a short time without complication.

## S019

LAPAROSCOPIC ADRENALECTOMIES IN ICELAND 1997-2005, A NATION WIDE OUTCOME, Bergthor Bjornsson MD, Margret Oddsdottir MD, Dept. Of Surgery, Landspitali-University Hospital, Reykjavik, Iceland

**BACKGROUND:** Laparoscopic adrenalectomy (LA) was first done in Iceland in June 1997. Since then all procedures for benign lesions of the adrenals have been done laparoscopically in a single center. Compared with conventional adrenalectomy, LA appears to achieve superior results in terms of recovery, hospital stay, cosmesis and morbidity.

**MATERIAL AND METHODS:** The hospital records of all patients that have had LA in Iceland since it was first done early in 1997 throughout 2005 were reviewed. Preoperative diagnosis was documented as was PAD, operative factors and complications as well as length of hospital stay.

**RESULTS:** In the study period 53 adrenal glands were removed from 48 patients in 49 operations. Women were 37 and male were 11. Mean patient age was 53,6 years (24,4-78,8). In 29 patients the left adrenal was removed, in 14 the right was removed and in 5 both adrenals were removed. Indications and diagnoses were 12 nonsecreting adenomas (all confirmed by PAD), 10 aldosteronomas (all confirmed), 10 pheochromocytomas (9 confirmed, 1 adrenal hyperplasia) and 6 because of gland size (3 adrenal gland hyperplasia, 1 cyst, 1 haemangioma, 1 normal adrenal gland) other indications and diagnoses were less common. Mean operative time was 168 min (87-370) for unilateral operations and 412 min (345-480) for bilateral operations. Mean bleeding was 117 ml (0-650) for unilateral operations and 200 ml (0-350) for bilateral operations. Complications were; mild pancreatitis (1), UTI (1), Atelectasis (1), CHF (2), transient corneal abrasion (1). No conversion to open procedure was needed. Mean size of surgical preparat was 6,8 cm (4,5-10,5 cm). Mean postop stay was 2,6 days (1-6 days).

**CONCLUSION:** The introduction of LA in Iceland for all benign lesions of the adrenals has been successful and without conversions or major complications. These nation wide results are comparable to results from large referral centers.

## S020

THE DEVELOPMENT AND TESTING OF A NEW SIMPLE FLEXIBLE ENDOSCOPIC SUTURING METHOD FOR INTRA-LUMINAL AND TRANSGASTRIC SURGERY (NOTES), WITH EARLY CLINICAL EXPERIENCE., Per-Ola Park MD, Maria Bergström MD, Keiichi Ikeda MD, Sandy Mosse PhD, Annette Fritcher-Ravens MD, Paul Swain MD, Sahlgrenska University Hospital, Gothenborg and Imperial College, London

**Background:** In order to perform advanced endoscopic treatments, like dealing with perforations, full-thickness resections one has to be able to close defects. There have been many devices constructed to perform endoscopic suturing, but all are rather complicated, expensive and difficult to use.

**Method:** 17 and 19G flexible needles constrained within a plastic catheter loaded with a metal tag, to which a 3-0 polypropylene thread was attached, were passed down the working-channel of a conventional endoscope. Two tags are placed into the wall of the stomach wall, one on each side of the defect. The threads are then locked together using a ring and pin (collet and sleeve method). The thread is cut using a guillotine. Precise stitch positioning is easily performed in the middle of the visual field. Multiple stitches can be placed quickly without the need to remove the endoscope during the procedure. An overtube is unnecessary and the device can be used with 9 mm flexible endoscopes with a 2.8mm channel. The component of this device all are CE marked. Ethical committee approval was received for the use of this method to oversew perforated ulcers in Gothenburg.

**Results:** By using this simple technique we were able to close perforations, perform gastro-jejunostomies and pyoplasty in experimental porcine models in survival animals. We have also been able to close perforated duodenal ulcer, leaking anastomosis and stop upper GI-bleeding successfully in patients when other methods of treatment had failed.

**Conclusions:** The above described technique is simple, easy to use and makes endoscopic suturing possible almost anywhere in the GI-tract which can be reached by a flexible endoscope. The suturing technique makes it possible to close perforations and approximate tissue without laparoscopic or open surgery. The first clinical results reported in three patients.

## S021

A NEW GENERATION OF FLEXIBLE ENDOSCOPE AND INSTRUMENTATION FOR ADVANCED ENDOSCOPY AND NOTES, Lee L Swanstrom MD, Richard A Kozarek MD, Nat D Soper MD, Legacy Health System, Portland, OR; Virginia Mason Medical Center, Seattle, WA; Northwestern University, Chicago, IL

**Background:** The concept of intraperitoneal flexible endoscopy has created a great deal of interest and investigation. Both gastroenterologists with a surgical leaning and surgeons with an advanced endoscopy interest are researching the feasibility of this new approach. Current flexible scopes and instruments are extremely limited for use in NOTES. We describe a current advanced endoscope specifically designed for endolumen and NOTES procedures and demonstrate feasibility in cadaver models.

**Technique:** In conjunction with industry, A 18 mm 4 channel rigidizing access device was designed. In addition, specific instruments which are larger (4.5mm) and more robust and which include tissue approximating tools are described. Measurements of the strength (torsional and lifting) of standard endoscopes and the new scope were compared. The new scope and instruments are used in 8 cadavers to document their feasibility and safety in a variety of specific tasks: upper abdomen and lower abdomen visualization, bowel manipulation, solid organ retraction and enterotomy application and closure.

**Results:** Benchtop comparison between a standard scope and the new scope showed equal maneuverability but the newer scope had greater force delivery at the tip (.042lbs vs 1.96lbs, p<.001) and greater instrument application force (.09 vs .23lbs, p<.002). Peroral introduction of the scope was possible in all cadavers but difficult in patients < 60kg.
<figure><img src="image_11.png" /></figure>

Intragastric manipulation was rated excellent and exiting the stomach was not difficult although it required a 2 cm gastro-tomy for the larger instrument. The scope system was easily maneuverable in the lower abdomen, accessing both lower quadrants without difficulty. The upper abdomen was view-able but there was variable success with steering the scope between left and right quadrants. The entire GI tract was able to be visualized from stomach to rectum. The scope generated sufficient force to lift and manipulate the bowel. Liver and spleen were uniformly able to be lifted and held with the curve of the scope. Using the tissue approximation device, secure full thickness closures were uniformly accom-plished.

**Conclusion:** A new flexible access endoscope with 4 large access channels showed utility in a cadaver setting – satisfy-ing some of the requirements to perform NOTES proce-dures and defining the next generation of operating endo-scopes.

## S022

### LAPAROSCOPIC SURGICAL TREATMENT OF EARLY STAGES GASTROINTESTINAL TUMORS CHASED BY MAGNETIC CLIP DETECTING AND CHASING SYSTEM (MCDCS), Takeshi Ohdaira BA, Hideo Nagai BA, Jichi Medical University
Laparoscopic gastrectomy and colectomy by a lesion-lifting procedure using a mucosa-nondamaging micromagnetic clip detecting and chasing system

**Background:** It is difficult to detect an early-stage cancer from the serosal side during laparoscopic gastrectomy and colectomy. However, it is necessary to resect the bowel while constantly detecting the site of lesion. We succeeded in the development of a laparoscopic, lesion-lifting proce-dure using a newly developed micromagnetic marking clip with special magnetic directivity. This new type of magnetic microclip allows tumor resection while easily detecting the site of the lesion and constantly chasing the site according to a marking clip-detecting and -chasing system(MCDCS).

**Methods:** Preoperative endoscopy was conducted to place a micromagnetic clip to the lesion periphery, and a stick-like device, which easily allows the change in tip magnetic flux density, was used to conduct tumor resection by lesion lift-ing during surgery. A micromagnetic body which we devel-oped can easily pass through the forceps hole of an endo-scope. Furthermore, the micromagnetic clip was designed and magnetized in such a manner to be endowed with spe-cial directivity to emit magnetic traction force in a direction which constantly does not damage the intestinal mucosal surface.

**Results:** The marking site was detected in 25 patients in a clinical study which used the prototype micromagnetic body. The mean length between the detection site and the clip along the longitudinal axis of greater curvature was 14.8 mm (SD: 9.2). The mean detection time was 7.7 sec (SD: 2.3). With an intention to complete the study in less than 1 minute, we eventually completed partial gastrectomy in 2 minutes. The micromagnetic body for MCDCS, which we developed this time, demonstrated its striking easiness for marking and its nondamaging activity on the mucosa.

**Conclusion:** A lesion-lifting procedure, which uses a mucosa-nondamaging, potent, micromagnetic clip and MCDCS, was suggested to possibly provide safety, effective-ness, and simplicity in laparoscopic gastrectomy and colec-tomy.

## S023

### A NOVEL METHOD FOR STAGING AND RESECTION OF INTRA ABDOMINAL CANCERS WITH LAPAROSCOPIC PET PROBES, Vivian E. Strong MD, John Humm PhD, Paul Russo MD, Doug Wong MD, Farhad Daghighian PhD, Murray Brennan MD, Yuman Fong MD, Steven Larson MD, Memorial Sloan-Kettering Cancer Center and IntraMedical Imaging
Positron Emission Tomography (PET) detects release of high-energy gamma emissions to detect and evaluate can-cer. However, correlating preoperative PET images with intraoperative findings remains a challenge. Although most clinical applications of PET in cancer have been with F-18

labeled fluorodeoxyglucose (to evaluate metabolic activity of tumors), PET has even greater potential for imaging other metabolic or immunologic markers. Since positron emitting isotopes emit both gamma and beta rays, we tested whether beta emission detected by hand held beta ray detectors would correlate with conventional gamma emis-sion detected by pre-operative PET scans, to improve intra-operative localization of tumor.

Within the context of IRB-approved protocols utilizing 124I labeled humanized monoclonal antibodies for colorectal cancer (Hu-A33) and renal tumors (cG250), hand-held detec-tors for beta and gamma emissions (PET-Probes TM) were used intra-operatively, on regions of intensity shown on pre-operative PET images and other regions suspicious for can-cer and also used ex vivo on tissue samples positive for tumor by H+E staining and autoradiography. Beta and gamma emissions were correlated. Metastatic colorectal cancer (n=4) and renal cell carcinoma (n=2) patients were evaluated with the hand-held probes during surgery per-formed post-injection of I-124 labeled antibodies. Gamma and beta emission from tumor and normal tissue were made in vivo and ex vivo and evaluated for pathology and by autoradiography.

The hand-held PET probes detected gamma and beta emis-sions from all tumors. Count rates of the gamma probe on the cancerous tissue ranged from 80 to 532 counts per sec-ond (cps) in vivo, and 72 to 278 cps ex vivo. For the beta probe these were 31 to 82 cpm in vivo and 34 to 95 cps ex vivo. Gamma and beta emissions exhibited a strong positive correlation. Beta emission showed a stronger correlation than gamma emission with overall tissue radioactivity. This study demonstrates that gamma emission detected by conventional PET imaging correlates directly with beta emis-sion in humans. Furthermore, this study suggests that com-pared to detection of gamma emission, beta emission detec-tion may offer superior real-time localization of tumor, par-ticularly as a laparoscopic version of this probe is tested in humans. Intraoperative portable PET probe may prove a useful bridge to combining tumor biology and PET technol-ogy to guide surgical therapy.

## S024

### DESIGN OF A NOVEL MULTIFUNCTION LAPAROSCOPIC TOOL TO SHORTEN OR TIME, David J Miller MS, Carl A Nelson PhD, Dmitry Oleynikov MD, University of Nebraska Medical Center, University of Nebraska-Lincoln

**Introduction:** With a limited number of access ports, mini-mally invasive surgery (MIS) often requires the complete removal of one tool and reinsertion of another. The investi-gators have designed a multifunction laparoscopic tool that can interchange six different instrument tips through the tool's shaft, facilitating multiple different functions in a sin-gle tool. Soft computing techniques can be used to optimal-ly arrange the tool's functional tips, allowing surgeons to deliver treatment of improved quality in less time, decreas-ing overall cost.

**Methods:** Endoscope video from MIS procedures performed at UNMC (e.g. cholecystectomy and gastrectomy) was obtained. This video was used to analyze the types of instru-ments used, the time of each use and the function of each instrument. These data were aggregated with fuzzy logic techniques to quantify the overall usefulness of each tool. This allowed subsequent optimization of the arrangement of functional tips within the modular tool to decrease overall time spent changing instruments.

**Results:** Based on the tool's design, the range of tool change times is approximately 11 to 13 seconds. The following table summarizes projected time savings over standard tools. Total surgery time (TST), actual time spent changing instru-ments (C), projected time spent changing modular instru-ments (PC), and time savings (TS) were obtained from the data (all values in minutes):
<figure><img src="image_12.png" /></figure>

<table><thead><tr><th>Procedure</th><th>A</th><th>B</th><th>C</th><th>D</th><th>E</th><th>F</th><th>G</th><th>H</th><th>I</th><th>J</th><th>K</th></tr></thead><tbody><tr><td>TST</td><td>48.7</td><td>20.7</td><td>88.2</td><td>127</td><td>95.7</td><td>115.5</td><td>101</td><td>48.2</td><td>125.3</td><td>42.7</td><td>26.1</td></tr><tr><td>C</td><td>7.2</td><td>9.1</td><td>16.3</td><td>30</td><td>18.7</td><td>30</td><td>11.4</td><td>12.4</td><td>39.9</td><td>5.7</td><td>3.5</td></tr><tr><td>PC</td><td>4.6</td><td>0.2</td><td>0.9</td><td>9.4</td><td>1.4</td><td>5.9</td><td>2.5</td><td>3.8</td><td>7.7</td><td>1.1</td><td>1</td></tr><tr><td>TS</td><td>2.6</td><td>9</td><td>15.3</td><td>20.5</td><td>17.3</td><td>24.1</td><td>8.9</td><td>8.6</td><td>32.2</td><td>4.7</td><td>2.5</td></tr></tbody></table>

**Conclusion:** Estimated time savings ranged from 2.5 to over 32 minutes, and on average, total surgery time can be reduced by 17% by using the multifunction tool. In addition, the use of a single tool for multiple functions overcomes the different tactile sensations caused by varying handle configurations, resulting in a standardized feel.

## S025

### DEVELOPMENT OF A NOVEL TOOL TO MORE PRECISELY ANALYZE POSTURAL STABILITY OF LAPAROSCOPIC SURGEONS, Gyusung Lee PhD, Adrian E Park MD, University of Maryland

Physical difficulties experienced by surgeons during MIS procedures are being given much attention by ergonomic researchers. We take postural stability, which has been insufficiently addressed, as a prime focus. The few studies now existing in this area have used Center of Pressure (CoP) alone to determine posture. Using CoP, we previously correlated postural stability to instrument type, task difficulty, and subject skill level. This study extends our investigative scope, particularly in terms of skill level, by broadening analysis to include Center of Mass (CoM) and what we uniquely term Postural Stability Demand (PSD). Six subjects with different levels of surgical experience were recruited to complete 3 FLS tasks: circle-cutting, endo-loop placement, and pegboard transfer. Subjects performed each while standing on 2 force plates while a motion capture system recorded body movements. CoP–at the bottom of the feet–is the point where ground reaction force is located. CoM is the point at which the mass of the body is concentrated. Principal Component Analysis was used to create an ellipse covering 95% of CoP and CoM excursions for calculation of sway area. PSD we characterize as the mean distance between CoP and CoM locations in anterior-posterior (A-P) or medial-lateral (M-L) directions. Postural parameters were correlated to performance time. During circle-cutting, less skilled subjects required longer times to complete the task and showed larger sway areas both in CoM and CoP (r=.858, p<.05; r=.779, p=.06). During endo-loop task, sway areas of CoM and CoP were smaller for less skilled subjects (r=-.899, p<.05; r=-.890, p<.05). These results indicate postural control differences between more and less experienced lap surgeons. No significant sway area correlation was found during pegboard transfer. Importantly, PSD in the A-P direction during all three tasks was strongly correlated with performance time (r=.744, p<.05; r=.913, p<.05; r=.772, p<.05). This indicates less skilled participants experienced increased postural demand equated with higher postural instability. This study demonstrated that variance in postural adjustments could be correlated to skill level and individual task. Strong correlation between PSD and performance time shows potential as an indirect predictive measure of surgical skill levels. Combining CoM, CoP, and PSD postural data results in a more robust analytical tool for identifying postural adjustments with skill level.

## S026

### TEMPERATURE SAFETY PROFILE OF LAPAROSCOPIC DEVICES: HARMONIC ACE (ACE), LIGASURE V (LV) AND PLASMA TRISSECTOR (PT), Fernando J Kim MD, Eduardo V Gewehr MD, Minoru Morihisa MD, Fernando Caldas MD, Marcelo Baptistussi MD, Edson Hayacibara MD, Adriano Campagna MD, Adrie VanBokhoven PhD, Hari Koul PhD, Denver Health Medical Ctr, Univ. of Colorado HSC

**Background:** Reports of surgeon's hand burn injuries caused by laparoscopic instruments during hand assisted surgery evoked questions about the temperature safety profile and the cooling properties of these instruments.

**Purpose:** We examined the temperature range generated by

each instrument using the pre-determined manufacturer's settings applied against different tissue/organs.

**Methods:** Video recording of temperatures generated by different instruments (ACE, LV and PT) were applied using manufacturers pre-set settings (coagulation/cutting) using the infrared camera IR-Flex Cam Pro on 3 different types of swine tissue: a) liver (L), b) peritoneum (P), and c) mesenteric vessels (MV). Activation and cooling temperature and time were measured for each instrument.

**Results:** Range of temperatures from each instrument and tissue application is defined in Table:

<table><thead><tr><th>Tissue</th><th>Device</th><th>Mean Temp (Celsius)</th><th>Change in temperature after OFF</th></tr></thead><tbody><tr><td>P</td><td>ACE</td><td>195.9±14.5 (149.4 - 234.5)</td><td>- 67.3 + 89.6 in 1-3 seconds</td></tr><tr><td>P</td><td>LV</td><td>88.9±2.7 (81.4 - 97.3)</td><td>- 7.9 to + 0.6 in 1-2 seconds</td></tr><tr><td>P</td><td>PT</td><td>87.2±2.0 (80.5 - 93.3)</td><td>- 8.7 to - 0.4 in 1-2 seconds</td></tr><tr><td>L</td><td>ACE</td><td>121.3±9.7 (99.5 - 156.1)</td><td>- 15.5 to + 24.4 in 1-4 seconds</td></tr><tr><td>L</td><td>LV</td><td>76.2±9.0 (64.8 - 80.0)</td><td>- 8.2 to + 2.5 in 1-3 seconds</td></tr><tr><td>L</td><td>PT</td><td>83.7±2.4 (74.4 - 87.8)</td><td>- 6.4 to + 6.7 in 1-2 seconds</td></tr><tr><td>MV</td><td>ACE</td><td>172.9±16.8 (127.6 - 229.8)</td><td>- 39.4 to + 31.4 in 2-6 seconds</td></tr><tr><td>MV</td><td>LV</td><td>96.3±4.1 (83.9 - 110.0)</td><td>- 29.0 to + 15.7 in 1-2 seconds</td></tr><tr><td>MV</td><td>PT</td><td>86.3±2.6 (78.1 - 92.7)</td><td>- 13.0 to + 16.0 in 1-7 seconds</td></tr></tbody></table>

**Conclusion:** All instruments increased peak temperatures after they were turned off requiring few seconds to cool down. The ACE generated very high temperatures that could harm adjacent tissue and potentially the surgeons hand when in contact with the instrument immediately after deactivation. Judicious use of these instruments may prevent burn injuries during laparoscopic procedures, particularly when using the ACE.

## S027

### COMPARISON OF BLOOD VESSEL SEALING AMONG NEW ELECTROSURGICAL AND ULTRASONIC DEVICES, William L Newcomb MD, William W Hope MD, Thomas M Schmelzer MD, Jessica J Heath BS, H J Norton PhD, Amy Lincourt PhD, B T Heniford MD, David A Iannitti MD, Carolinas Medical Center

**Background:** Bipolar electrosurgical devices and ultrasonic devices are routinely used in open and advanced laparoscopic surgery for hemostasis. New electrosurgical and ultrasonic instruments are available that offer improvements in blood vessel sealing compared to devices used previously. The purpose of this study was to compare burst pressure, sealing time, and failure rate among these new vessel sealing devices.

**Methods:** Five millimeter laparoscopic instruments tested included Gyrus PKS™ Cutting Forceps (GPK), Gyrus Plasma Trisector™ (GPT), Harmonic Scalpel® (HS), EnSeal™ Tissue Sealing and Hemostasis System (ES), LigaSure™ V with LigaSure™ Vessel Sealing Generator (LS), LigaSure™ V with Force Triad™ Generator (FT), and Ligamax™ 5 Endoscopic Multiple Clip Applier (LM). Each device was used to seal 13 small (2-3mm diameter), 13 medium (4-5mm diameter), and 13 large (6-7mm diameter) arteries from euthanized pigs. Burst pressure (mmHg), sealing time (s), and percent failure rates were determined for each device. The SAS® software was used for all statistical analyses. P<0.05 was considered statistically significant.

**Results:** For 2-3mm vessels, mean burst pressures were not statistically different for any device. For 4-5mm vessels, LS had the highest mean burst pressure recorded and was statistically higher than all instruments other than LM, ES, and FT. No electrosurgical or ultrasonic device had statistically different burst pressures for 6-7mm vessels. Mean seal times were statistically shorter for every vessel size when the FT was compared to LS. The shortest sealing times for 2-3mm vessels were recorded for the GPT. The shortest sealing times for medium and large vessel sizes were observed with FT. The highest percent failure rate for each vessel size was seen with the GPT. For 4-5mm diameter vessels, failure rate was 48.39% for GPT, 40.91% for GPK, and 22.2% for HS. For 6-7mm diameter vessels, failure rate was 91.67% for GPT, 40.91% for GPK, and 7.94% for HS. LM and FT had no recorded failures.

**Conclusions:** Among the new 5mm laparoscopic electrosurgical and ultrasonic instruments available for testing, ES, LS, and FT produced the highest mean burst pressures. FT
had the shortest mean seal times for medium and large size vessels. Minimal or no seal failures were seen with HS, ES, LS, LM, and FT.

## S028

### HISTOPATHOLOGIC COMPARISON OF FOUR ENERGY-BASED VASCULAR SEALING AND CUTTING INSTRUMENTS: A PORCINE MODEL.

Benjamin Person, David A. Vivas, Dan Ruiz, Michael Talcott, James E. Coad, Steven D. Wexner, Cleveland Clinic Florida, Weston, Florida

**Aim:** To compare the efficacy and safety of four energy-based vascular sealing and cutting instruments.

**Methods:** Blood vessels of various types and diameters were harvested from 4 pigs using 4 instruments: Harmonic ACE, LigaSure V and Atlas and EnSeal vessel fusion system. The diameters of the vessels, speed of the cutting and sealing and the bursting pressure of the sealed end were compared. An additional set of specimens was sealed and left in situ for up to 4 hours after which the vessels were harvested and sent for histopathological evaluation of the degree of thermal injury.

**Results:** The parameters of vessel diameter, speed of seal and bursting pressures are summarized in table 1. The bursting pressures were significantly the highest with EnSeal compared to all other instruments (p<0.0001). The sealing process was significantly the shortest with Harmonic ACE and significantly the longest with LigaSure Atlas (p<0.0001). The mean seal width was significantly the largest with the LigaSure Atlas compared to the other instruments (p<0.0001), and it was the smallest with EnSeal and Harmonic ACE. Radial adventitial collagen denaturation was significantly smaller with EnSeal and LigaSure V than with the other 2 instruments (p<0.0001); EnSeal caused less collagen denaturation than LigaSure V, with no statistical difference (p=0.07). Proximal thermal injury to the smooth muscle in the media was least common with LigaSure Atlas than with the other instruments although the numbers were too small for statistical analysis. **Conclusions:** The bursting pressures with EnSeal are significantly higher than all the other instruments. Harmonic ACE is the fastest sealing instrument and LigaSure Atlas the slowest. EnSeal creates significantly less thermal damage to the adventitia of the vessels and LigaSure Atlas significantly less thermal damage to the media of the vessels compared to the other instruments. The clinical significance of these findings is unknown.

<table><thead><tr><td>Instrument</td><td>Vessel diameter (mm)</td><td>Speed (s)</td><td>Burst pressure (mmHg)</td></tr></thead><tbody><tr><td>EnSeal</td><td>4.1±1.5</td><td>4.1±0.9</td><td>677.8±184.4</td></tr><tr><td>LigaSure Atlas</td><td>4.8±0.6</td><td>7.9±2.2</td><td>489.2±269.9</td></tr><tr><td>LigaSure V</td><td>3.8±1.6</td><td>5.2±2.1</td><td>379.5±135.1</td></tr><tr><td>Harmonic ACE</td><td>3.3±1.0</td><td>3.3±1.0</td><td>434.7±320.7</td></tr></tbody></table>

## S029

### PRELIMINARY RESULTS OF LAPAROSCOPIC ADJUVANT INTRAPERITONEAL CHEMOHYPERTHERMIA (IPCH) IN PATIENTS OPERATED FOR LOCALLY ADVANCED COLORECTAL OR GASTRIC CANCER, élie k chouillard MD, toufic j ata MD,bernard de jonghue MD,jean-charles etienne MD,eva ghiles MD,hervé outin MD,abe l fingerhut MD, Departments of Gastrointestinal Surgery_ and Critical Care Unit_, Centre Hospitalier, Poissy, FRANCE

Intraperitoneal chemohyperthermia (IPCH) may be part of the management of patients with peritoneal carcinomatosis of colorectal or gastric origin. However, its role is not fully documented in patients with locally advanced colorectal and gastric cancer, usually at high risk of developing future peritoneal carcinomatosis. We evaluated the feasibility and the short-term morbi-mortality of IPCH in such patients.

**Methods:** On January 2006, we started a prospective evaluation of a protocol of adjuvant IPCH in patients who had R0 resection for locally advanced gastric or colorectal cancer. Eligible patients had laparoscopic IPCH. The procedure was performed either immediately after primary resection or secondarily. Twelve litres of heated serum were delivered through a pump system under electronic control of intraab-

dominal temperature maintained between 41°C and 43°C. Mitomycin and cisplatinine were used.

**Results:** Twenty one patients (15 women and 6 men, mean age 55 years (41-74)) had laparoscopic IPCH. Sixteen patients had colorectal cancer and 5 patients had gastric cancer. IPCH was performed after a mean interval of 5 weeks (0-8) after primary surgery. No conversion to laparotomy or operative incident occurred. There was no 30-day or intra-hospital mortality. Overall morbidity rate was 19 % (6 complications in 4 patients) including two bone marrow aplasia, two intraabdominal abscesses, one pneumonia, and one pulmonary embolism. One patient was reoperated for pelvic abscess.

**Conclusion:** Adjuvant laparoscopic IPCH in patients operated for locally advanced colorectal or gastric cancer is feasible and sure. Short-term mortality and mortality are relatively low. Possible impact on overall survival or disease-free survival needs further evaluation.

## S030

### TRUE INCIDENCE OF PORT SITE METASTASIS (PSM) FOLLOWING MINIMALLY INVASIVE ONCOLOGIC SURGERY, Chandrakanth Are MD, Kevin J Koomalsingh MD, Khadir Kakal MD, Bernard Park MD, Vivian Strong MD, Murray F Brennan MD, Nadeem R Abu-Rustum MD, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Maimonides Medical Center, Brooklyn, NY, USA.

**Introduction:** PSM are still a concern for oncologic surgeons with varying rates reported in the literature. The aim of this study was to determine the true incidence of PSM following laparoscopy or thoracoscopy for malignancies of various organ systems in a large series of patients from a tertiary care cancer center.

**Materials and methods:** All patients that underwent laparoscopy or thoracoscopy for gastrointestinal, gynecological and thoracic malignancies were identified from prospectively maintained institutional databases. (1991-2003). A thorough review of the databases was performed to identify patients with PSM.

**Results:** A total of 2148 procedures were performed in 2069 patients with gastrointestinal, gynecological and thoracic malignancies accounting for 527, 1288 and 254 patients respectively. The incidence of PSM for the entire cohort of patients was 1.26% (26 patients). PSM were noted in 9/527 (1.7%), 13/1288 (1%) and 4/254 (1.57%) patients with gastrointestinal, gynecological and thoracic malignancies, respectively. The median interval to detection of PSM was 6 months (range- 2 weeks to 28 months). Of the 26 patients with PSM, only 3 patients (0.14%) were noted to have true PSM (isolated single site of disease at port site). The remaining 23 patients had PSM in association with carcinomatosis (16 patients- 0.77%) or in the presence of intra-peritoneal catheter (7 patients- 0.34%).

**Conclusion:** Isolated port site metastasis following minimal-ly invasive oncologic surgery is rare. The majority of the port site metastasis occur in the context of systemic spread of malignancy and therefore could represent a surrogate marker of ensuing advanced disease.

## S031

### THE USE OF SELF-EXPANDING SILICONE STENTS IN ESOPHAGEAL CANCER CARE: OPTIMAL PRE-OPERATIVE, PERI-OPERATIVE AND POST-OPERATIVE CARE, Robert Martin MD, Ryan Duvall BS, Charles R Scoggins MD, University of Louisville, Department of Surgery, Division of Surgical Oncology

**Introduction:** Preoperative nutritional supplementation, management of esophageal leaks, and post-operative anastomotic strictures still remain a common problem in the management of esophageal cancer. Jejunal feeding tubes, TPN with nasogastric suction, and repeated esophageal dilations remain the most common treatments respectively, but are not optimal for efficient patient management and quality of life. Thus the aim of this study was to evaluate the use of removable silicone stents in 1) The pre-operative nutritional optimization during neoadjuvant therapy, 2) The manage-
<figure><img src="image_13.png" /></figure>

ment of peri-operative anastomotic leak, and 3) the management of post-operative anastomotic strictures.

**Methods:** Review of our prospectively maintained esophageal database identified 20 patients who had removable self-expanding silicone stents placed in the management of one of these three management problems from July 2004 to August 2006.

**Results:** Pre-operative Therapy:: Five patients underwent initial stent placement in preparation for neoadjuvant therapy. Dysphagia relief was seen in 100% of patients, with optimal caloric needs taken within 24 hours of placement. All patients tolerated neoadjuvant therapy without delay from dehydration or malnutrition. One stent migration was found at the time of operation, which was removed without sequelae.

**Peri-operative therapy::** Five patients developed delayed (>10 days) esophageal leaks that were managed with removable esophageal stent and percutaneous drainage (in 3 patients). All patients had successful exclusion of the leak on the day of the procedure with resumption of oral intake on the evening of procedure. All five healed leaks without sequelae.

**Post-operative Therapy::** Ten patients developed post-operative anastomotic strictures that required dilation and placement of removable esophageal stent. The median number of dilations was 1 (range 1-2), with all stents placed for 3 months duration. All patients had immediate dysphagia relief after stent placement.

**Conclusion:** Continued improvements in pre-operative, peri-operative, and post-operative management is needed to improve patient therapy and minimize the quality of life effect from this disease and its therapy. Removable esophageal stents are novel treatment option to optimize relief of symptoms and return the patients back to a more normal oral intake. Continued evaluation is needed to consider stent use as first line therapy.

## S032

**MINIMALLY INVASIVE ESOPHAGECTOMY FOR CANCER: TOTALLY LAPAROSCOPIC TRANSHIATAL APPROACH OR THORACOSCOPY IN PRONE POSITION FOLLOWED BY LAPAROSCOPY?**, Giovanni Dapri MD, Jacques Himpens MD, Elie Capelluto MD, Jean Louis Majcher MD, Guy Bernard Cadiere PhD, Department of Gastrointestinal Surgery, European School of Laparoscopic Surgery, Saint-Pierre University Hospital, Brussels, Belgium

**Background:** Esophageal anatomy and characteristics of patients affected by esophageal cancer invite surgeons to a minimal invasivity. This retrospective study compares two techniques of esophagectomy for cancer: transhiatal laparoscopy (A) versus right thoracoscopy in prone position followed by laparoscopy and cervicotomy (B).

**Methods:** Between April 1999 and August 2005, 24 patients (A) and 15 patients (B) underwent to minimally invasive esophagectomy for cancer in our Department. Average age was 61,2 years (A) and 60,4 years (B). Preoperatively endoscopic localization of the tumor was upper third in 2 cases (1 vs 1), middle third in 11 cases (7 vs 4) and lower third in 26 cases (16 vs 10). Preoperatively endoscopic stage was: 0 in 2 cases (0/24 vs 2/15), I in 8 cases (5/24 vs 3/15), IIa in 12 cases (7/24 vs 5/15), IIb in 6 cases (4/24 vs 2/15), III in 9 cases (6/24 vs 3/15) and IV in 2 cases (2/24 vs 0/15). Six patients of A underwent additional neo-adjuvant therapy.

**Results:** Median operative time was 300 minutes (240-420) for A and 420 minutes (240-540) for B (p=0,01). Median peroperative bleeding was 325 ml (100-800) for A and 700 ml (100-2400) for B (NS). Peroperative complications was 1 splenectomy for both groups and 1 conversion into thoracotomy for B. Postoperative medical complications were 5 (A) and 6 (B). Postoperative surgical complications were 1 hemoperitoneum, 1 pneumothorax, 4 anastomotic leaks (A) and 4 anastomotic leaks, 1 colic leak, 2 tracheal necrosis, 2 hiatal hernias (B). Median intensive care stay was 5 days (2-70) for A and 5 days (1-180) for B (NS). Median hospital stay was 12 days (7-98) for A and 14 days (7-480) for B (p=0,05). Early mortality was 0%. All specimens were free of disease; median number of mediastinal/periesophageal lymph nodes

was 3 (1-10) for A and 4 (2-13) for B (NS); median number of celiac/perigastric lymph nodes was 11 (2-31) for A and 10 (3-22) for B (NS). After a mean follow-up of 42,4 months (2-84) for A and 19,1 months (1,5-34) for B, total survival rate is respectively 8/24 (33,3%) and 8/15 (53,3%).

**Conclusions:** This retrospective study shows significant differences between these two techniques in term of operative time and hospital stay, in favour of the transhiatal approach.

## S033

**LAPAROSCOPIC GASTRECTOMY FOR GASTRIC CANCER - AN EXPERIENCE OF OVER 600 CASES-**, Shinya Tanimura MD, Masayuki Higashino MD, Yosuke Fukunaga MD, Yoshinori Tanaka MD, Yushi Fujiwara MD, Osaka City General Hospital As less-invasive operations have been noted in recent years, laparoscopic gastrectomy for gastric cancer has become popular because of advances in surgical techniques. We have performed laparoscopic gastrectomy with regional lymph node dissection on 612 cases of gastric malignancies between March 1998 and August 2006. Here we present the technique and results of laparoscopic gastrectomy for gastric cancer.

Of all 612 cases, distal gastrectomy was performed on 485 cases, proximal gastrectomy on 42 cases, and total gastrectomy on 85 cases, respectively. For all cases, D1 or D2 lymph node dissection was carried out according to the general rule of Japanese Gastric Cancer Association.

The average duration of operation and the amount of blood loss were 248 minutes (distal: 242, proximal: 246, total: 286) and 193 mL (distal: 165, proximal: 225, total: 337). The post-operative days of flatus, oral feeding and hospital stay were 2.6 (distal: 2.5, proximal: 3.0, total: 2.9), 3.5 (distal: 3.3, proximal: 4.3, total: 4.6) and 12.4 days (distal: 11.8, proximal: 13.9, total: 15.3), respectively. The average of tumor diameter was 32.4 mm (distal: 31.2, proximal: 27.5, total: 41.2) and the number of harvested lymph nodes per patient was 29.2 (distal: 29.1, proximal: 22.3, total: 33.8), respectively.

Recurrence was recognized only in six (two T1 and four over T2 cases) of all patients so far.

In conclusion, laparoscopic gastrectomy for gastric cancer is considered less-invasive and as curative as compared to the conventional open gastrectomy.

## S034

**LAPAROSCOPIC GASTRIC RESECTION FOR GASTROINTESTINAL STROMAL TUMORS**, Jennifer A Spitler MD, Richard A Pierce MD, Valerie J Halpin MD, Christopher Eagon MD, William G Hawkins MD, David C Linehan MD, Michael Brunt MD, Margaret M Frisella RN, Brent D Matthews MD, Department of Surgery, Washington University, St Louis, Missouri

**INTRO:** The purpose of this study is to review the clinical outcomes for patients selected to undergo a laparoscopic resection for a gastrointestinal stromal tumor (GIST) of the stomach.

**METHODS:** All laparoscopic gastric resections (n=100) performed from Feb 1995 to July 2006 were reviewed under an IRB-approved protocol. Pre- and postoperative variables including complications, pathology and tumor recurrence were analyzed. Data are given as mean ± SD.

**RESULTS:** Laparoscopic gastric resection was attempted for 56 GIST in 55 patients (29:26; M:F) with a mean age of 58.7 years ± 19.5. The tumors were located at the GE junction/cardia (n=7), fundus (n=17), body (n=16), antrum (n=14) or pylorus (n=2). The most common presentation was an UGI bleed (n=26) or incidental finding on EGD (n=12). Laparoscopic procedures performed were partial gastrectomy (n=45), antrectomy (n=4), esophagogastrectomy (n=3) and endoscopic-assisted transgastric resection (n=3). One patient was converted to an open procedure to control bleeding from the spleen. Mean tumor size was 3.8 cm ± 1.8. Negative surgical margins were achieved in all but one case. Mean operative time was 156 min ± 68 and mean EBL was 105 ml ± 212. Regular diet was resumed at a mean of 2.8 days ± 1.5 and mean LOS was 3.9 days ± 2.2. Perioperative complication rate was 18.2% including a DVT,
a postoperative bleed requiring re-exploration on POD #1, an anastomotic stricture requiring dilatation at 3 months and incisional hernia at 12 months follow-up. There was one postoperative death from respiratory failure. Forty-three GIST were low risk (<=5 cm, <5 mit/50 HPF), 8 GIST were intermediate risk (<5 cm, 6-10 mit/50 HPF or 5-10 cm, <5 mit/50 HPF) and 5 GIST were consider to be of high malignant potential (>5 cm, >5mit/50 HPF or >10 cm, any mitotic rate or any size, >10 mit/50 HPF). After a mean follow-up of 15 months ± 21.8 (range, 0-103), 3/8 patients with high malignant potential GIST developed metastatic disease to the liver, liver and lung, and peritoneum, respectively. All other patients are disease free.

**CONCLUSIONS:** Laparoscopic resection for GIST is a feasible option for tumors located in the stomach. Adequate oncologic resection was successfully achieved in 98.2% of patients chosen for a laparoscopic resection. Resection margin positivity and recurrence rates are low after a minimally invasive approach in appropriately selected patients with GIST demonstrating favorable characteristics.

## S035

### FACTORS AFFECTING LYMPH NODE RETRIEVAL IN COL-ORECTAL CANCER SURGERY, Michelle A Ostadi, Julie

Harnish MSc, David R Urbach MD, Department of Surgery, University Health Network, Toronto, ON, Canada

**INTRODUCTION:** Staging of colorectal cancer is dependent on the number of lymph nodes (LN) in a surgical specimen that are positive for metastatic cancer. The American Joint Committee on Cancer (AJCC) recommends a minimum of 12 LNs be examined to ensure adequate staging. It is unclear which factors specifically contribute to variation in the number of LNs retrieved from surgical specimens. This study aims to understand the factors affecting the number of LNs identified in colorectal cancer surgical specimens.

**METHODS:** A total of 264 retrospectively collected cases of colorectal cancer surgically treated at the University Health Network in Toronto from 2004 to 2006 were analyzed. We used univariate ANOVA and multivariate linear regression analysis to determine the variation in LN number associated with age, gender, surgeon, pathologist, pathology assistant, primary vs. recurrent, tumor site, neoadjuvant radiotherapy, admission category, and laparoscopic vs. open surgery.

**RESULTS:** The average number of LNs retrieved per case was 18.1. Of the 264 cases, 70 (26.5%) contained fewer than 12 nodes. The variables we examined accounted for 31.8% of variation in LN number. Variation in LN number was greatest between different pathology assistants (P=<0.001). Mean number of nodes retrieved by different pathology assistants ranged from 12.6 to 29.7. On average, surgery for recurrent cancer removed 6.0 (95% CI 1.2 to 10.9, P=0.02) fewer LNs than for primary cancer. Each additional year of patient age was associated with retrieval of 0.1 (95% CI 0.04 to 0.2, P=0.005) fewer nodes. Laparoscopic surgery retrieved 3.4 (95% CI 0.1 to 6.9, P=0.06) fewer LNs than open surgery, and rectal cancer specimens had 2.7 (95% CI 0.04 to 5.4, P=0.05) fewer LNs than colon cancer specimens. Other factors analyzed were not associated with statistically significant variation in LN number.

**CONCLUSIONS:** Most of the variation in the number of colorectal cancer LNs retrieved at our hospital that could be explained by statistical modeling was accounted for by differences between pathology assistants. Recurrent cancer, older patients, and rectal cancer were also associated with fewer LNs.

## S036

### ENDOLUMINAL SURGERY OFFERS A SAFER TREATMENT OPTION FOR RECTAL NEOPLASMS IN HIGH RISK

**PATIENTS,** Daniel H Hunt MD, Lauren A Kosinski MD, John H Marks MD, Gerald J Marks MD, The Lankenau Hospital and Institute for Medical Research, Wynnewood, PA

**Introduction:** In the management of rectal neoplasms avoidance of a major abdominal procedure and/or stoma is particularly desirable in high risk patients. To determine the ability of endoluminal surgery to expand safer treatment options for patients at high risk as identified by the

American Society of Anesthesiologists physical status classification (ASA) above II, and/or morbid obesity, and/or pelvic irradiation we investigated outcomes in such patients undergoing transanal endoscopic microsurgery (TEM) excision for benign and malignant rectal neoplasms.

**Methods:** Patients with a body mass index (BMI) above 30 (kg/m2), and/or ASA above II, and/or pelvic irradiation were selected from a prospective database consisting of 142 consecutive TEM procedures performed by a single surgeon. The postoperative morbidity, mortality, recurrence rates, and need for a permanent or temporary ostomy were assessed.

**Results:** Ninety three patients, 33 women and 60 men, with an average age of 69 years (29-91) qualified for inclusion. Thirty eight (40%) had a BMI above 30 (30-52), 40 (43%) had pelvic irradiation (4,320-5,580 cGy) and 73 (78%) had an ASA above II. Mean follow up was 25 months. Primary diagnoses were: 43 adenocarcinomas (40 with neoadjuvant therapy), 39 benign polyps, 6 carcinoma in situ, and 3 carcinoids. Thirty five patients referred specifically for sphincter preservation surgery and 22 sought referral after being advised they required abdominal perineal resection (APR). Sixty five (72%) tumors involved lower third of the rectum, 21 (23%), and 4 (5%) involved the middle and upper thirds respectively. No perioperative deaths; 2 patients: major postoperative wound separation requiring temporary colostomy; 10 developed minor wound separation; 3 postoperative transient fever; 2 arrhythmias; and 1 mild postoperative bleeding. Among 43 cancers pathological T staging: 10: T1, 22: T2, and 7: T3. Two patients required a subsequent APR; 1 for recurrent carcinoma and 1 for a T3N1 rectal carcinoma. There were 3/43 (7%) local pelvic recurrences.

**Conclusion:** Short term results of our experience indicates endoluminal TEM surgery offers a safe alternative to abdominal partial or total proctectomy in the high risk patient for whom local excision of a rectal tumor is oncologically appropriate. As an additional benefit TEM allows avoidance of a temporary or permanent stoma in the vast majority of patients.

## S037

### TRANSANAL ENDOSCOPIC MICROSURGERY IN THE TREATMENT OF SELECTED PATIENTS WITH DISTAL REC-TAL CANCER: EXPERIENCE OF 15 YEARS, Mario Guerrieri

**MD, Maddalena_** Baldarelli MD, Angelo _ De Sanctis MD, Lorenzo _ Organetti MD, Martina _ Nisi MD, Giovanni _ Lezoche MD, Emanuele _ Lezoche BA, _ Dpt of General Surgery, University of Ancona _ II Clinica Chirurgica, University "La Sapienza", Rome

**PURPOSE:** Local therapy of early rectal cancer is a valid alternative to the classical radical operation which has a higher morbidity and mortality rate. The use of high dose preoperative radiation appears to enhance the options for sphincter saving surgery also in T2-T3 rectal patients (pts) with effective local control. We report our experience with the use of Transanal Endoscopic Microsurgery (TEM) in the management of selected cases of distal rectal cancer without evidence of nodal or distant metastasis (N0-M0).

**METHODS:** 196 pts with rectal cancer (51 T1, 84 T2 and 61 T3) were enrolled in the study. All pts staged preoperatively as T2 and T3 underwent preoperative high dose radiotherapy and since 1997 pts with less than 70 years old and good general conditions underwent also preoperative chemotherapy.

**RESULTS:** Minor complications were observed in 17pts (8.6%) whereas major complications only in 2 patients (1%). The definitive histology was as follows: 33 pT0 (17%), 73 pT1 (37%), 66 pT2 (34%) and 24 pT3 (12%). Eight pts (5 pT2 and 3 pT3) developed local recurrence (4,1%) The rectal cancer specific survival rate at the end of follow-up was 100% for T1 and 96% and 76% for T2 and T3 pts respectively.

**CONCLUSIONS:** Pts with T1 cancer and favourable histologic features may undergo local excision alone, while those with T2 and T3 lesions require preoperative radio-chemotherapy. The results reported after TEM seems to be not substantial different in terms of local recurrence and survival rate to the results reported after conventional surgery.
<figure><img src="image_14.png" /></figure>

## S038

**A RESEARCH AGENDA IN GASTROINTESTINAL AND ENDO-SCOPIC SURGERY**, David R Urbach MD, Karen D Horvath MD, Nancy N Baxter MD, Blair A Jobe MD, Atul K Madan MD, Aurora D Pryor MD, Leena Khaitan MD, Alfonso Torquati MD, Steven T Brower MD, Thadeus L Trus MD, Steven D Schwaitzberg MD, Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)

**Background:** Development of a research agenda may help inform researchers and research granting agencies about the key research gaps in an area of research and clinical care. We sought to develop a list of research questions for which further research was likely to have a major impact on clinical care in the area of gastrointestinal and endoscopic surgery.

**Methods:** We used a formal group process to conduct an iterative, anonymous web-based survey of an expert panel consisting of the general membership of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). In round 1, we solicited research questions, which were categorized, collapsed, and re-written in a common format. In round 2, the expert panel rated all the questions using a priority scale ranging from 1 (lowest) to 5 (highest). In round 3, the panel re-rated the 40 questions with the highest mean priority score in round 2.

**Results:** 241 respondents to round 1 submitted 382 questions, which were reduced by a review panel to 106 unique questions encompassing 33 topics in gastrointestinal and endoscopic surgery. In the 2 successive rounds, 397 and 385 respondents ranked the questions by priority and then re-ranked the 40 questions with the highest mean priority score. High priority questions related to anti-reflux surgery, the oncologic and immune effects of minimally invasive surgery, and morbid obesity. The question with the highest mean priority ranking was: "What is the best treatment (antireflux surgery, endoluminal therapy or medication) for GERD?" The second highest-ranked question was: "Does minimally invasive surgery improve oncologic outcomes as compared with open surgery?" Other questions covered a broad range of research areas including clinical research, basic science research, education and evaluation, outcomes measurement, and health technology assessment.

**Conclusions:** We used an iterative, anonymous group survey process to develop a research agenda in gastrointestinal and endoscopic surgery, consisting of the 40 most important research questions in the field. This research agenda can be used by researchers and research granting agencies to focus research activity in the areas most likely to impact clinical care and to appraise the relevance of scientific contributions.

## S039

**OPEN SURGERY IS ASSOCIATED WITH SUSTAINED ELEVATION OF CIRCULATING PDGF-BB, A KNOWN TUMOR GROWTH PROMOTER, WHEN COMPARED TO MINIMALLY INVASIVE SURGERY**, A Belizon, A Hoffman, S Kumara, PK Horst, D Feingold, T Arnell, M Foster, A Offodile, D Moradi, RL Whelan, New York Presbyterian Hospital-Columbia Campus

**Introduction:** Open surgery has been associated with increased tumor growth when compared to minimally invasive surgery (MIS) in animal models; the cause remains unclear. Platelet derived growth factor-BB (PDGF-BB) is a potent angiogenic cytokine that has been shown to facilitate tumor growth in vitro. We have earlier shown that preoperative (preop) levels of PDGF-BB are significantly elevated in colorectal cancer patients when compared to those with benign disease. PDGF-bb is also an important factor in postoperative wound healing. In this study we evaluated plasma PDGF-BB levels postoperatively (postop) in both open and closed colorectal cancer patients.

**Methods:** Preop and postop day 2 and 3 plasma PDGF-BB levels were measured by ELISA in a total of 92 patients undergoing colorectal cancer resection. 48 patients underwent open surgery and 44 patients underwent MIS. Wilcoxon matched pairs test was used to compare PDGF-bb levels within groups, the levels at a particular time point

between groups were analyzed using the Mann-Whitney U test.

**Results:** The open and MIS groups were comparable in regards to cancer location and resection performed. Mean incision size was 17.6cm in the open group and 6.1cm in the MIS group. The open group median preop PDGF level (1737pg/ml) declined on POD 2 (1666pg/ml, p=NS vs Preop). In the MIS group the preoperative plasma PDGF-bb level (1817pg/ml) significantly decreased on POD2 (1355, p=0.0002). The POD#3 levels for both groups continued to decrease and were similar (Open-866.3 pg/ml, lap-908 pg/ml; vs preop for both, p=0.0001). The rate of decline in the MIS group was 31% in the first 48 hours and 46% after 72 hours. The rate of decline in the open group was 4% in the first 48 hours and 44.2% after 72 hours.

**Conclusion:** Although many cancers produce PDGF-bb, surgical wounds may be another source. Although by POD3 similar levels were noted, open surgery is associated with higher levels of PDGF-bb early after surgery. This may be due to PDGF-bb production associated with the larger abdominal wound. Although unproven, this sustained elevation might impact the growth of residual tumor microfoci and circulating tumor cells. Further studies are needed to determine if these findings are clinically relevant and to determine late postop levels.

## S040

**VALIDATION OF A RODENT MODEL OF BARRETT'S ESOPHAGUS USING QUANTITATIVE GENE EXPRESSION PROFILES**, Daniel S Oh MD, Steven R DeMeester MD, Christy M Dunst MD, Bethany J Lehman BS, Hidekazu Kuramochi MD, Erlinda L Kirkman DVM, Paul Kirkman BS, Jeffrey A Hagen MD, John Lipham MD, Tom R DeMeester MD, University of Southern California

**BACKGROUND:** There are few experimental models of GERD and Barrett's esophagus (BE). One that is commonly used involves surgically inducing reflux in rats by creating an esophagojejunostomy near the ligament of Treitz. This results in the development of intestinal-type columnar mucosa in the distal esophagus similar to BE in humans. However, this columnar mucosa is often short and it is unknown if this is truly intestinal metaplasia as a consequence of reflux or if it merely represents migration of adjacent jejunal mucosa across the anastomosis. The aim of this study was to use quantitative gene expression to determine a gene profile of the columnar mucosa located proximal to the anastomosis in this model and compare it to normal rat jejunal mucosa in order to determine the origin of this columnar esophageal mucosa.

**METHODS:** Seven 8-week old male Sprague-Dawley rats had ligation of the gastroesophageal junction and reconstruction with esophagojejunostomy just distal to the ligament of Treitz. After 30 weeks the rats were euthanized and the distal esophagus, proximal jejunum, and colon were harvested from each. Tissue was microdissected to obtain only the mucosal cells of interest. Total RNA was isolated, reverse transcribed to cDNA, and RT-PCR was used to measure the mRNA expression of trefoil factor (TFF)-1, -2, and -3, informative genes for distinguishing BE from small intestine in humans. Principal components analysis was used to compare the expression profiles.

**RESULTS:** All 7 rats had columnar mucosa in the distal esophagus proximal to the anastomosis, and in all cases goblet cells were present on H&E staining. The length of columnar mucosa was 1 to 5 mm. Principal components analysis of the gene expression data classified 4 esophageal samples (57%) as distinctly different from normal rat jejunum or colon, while the remaining 3 (43%) were classified as jejunum.

**CONCLUSION:** We confirm that the rat esophagojejunostomy model can produce intestinal metaplasia in the distal esophagus with a significantly different genetic profile than that of normal rat intestine, suggesting that this is similar to BE in humans. The inability of gene profiling to distinguish the esophageal columnar mucosa from normal rat intestine in 3 animals may reflect creeping of jejunal mucosa above
<figure><img src="image_15.png" /></figure>

the anastomosis in these animals rather than true metaplasia. Future studies using this model should use this gene panel to confirm that the columnar mucosa is truly metaplastic.

## S041

**MICRODIALYSIS AS A NEW METHOD FOR EVALUATING OF INFLUENCE OF PNEUMOPERITONEUM ON THE KIDNEY:**
**EXPERIMENTAL STUDY**, Takashi Iwata MD,Greg Nowak MD,Bo-Goran Ericzon MD, Department for CLINTEC, Division of Transplantation Surgery, Karolinska Institute, Karolinska University Hospital, Huddinge

**Background:** Nowadays, laparoscopic donor nephrectomy is a less invasive technique for the donor than a conventional open donor operation and has become the first choice for living donor kidney transplantation. Many experimental and clinical studies about the influence of increased intra-abdominal pressure on graft have showed that micro- and macro-circulation of abdominal organs and tissues are reduced, and this condition is thought to cause severe damage on splanchnic organs. However there is not enough monitoring method to evaluate hemodynamic and metabolic changes in kidney during and after pneumoperitoneum. Microdialysis is a technique to monitor the matebolic state of organ itself, based on a chemistry analysis over time with sampling of interstitial compounds using membrane based dialysis sacs. In physiological conditions during glycolysis, glucose is metabolized into pyruvate, and in the presence of oxygen, pyruvate enters the citric acid cycle. During ischemia lactate is produced from pyruvate in order to maintain anaerobic glycolysis with low energy production. Therefore, monitoring of lactate and pyruveta levels reveals whether aerobic metabolism is occurring in the organ. Glycerol is an end product of lipolysis in adipose tissue and is also an indicator of membrane disintegration during such events as ischemia. All these parameters of ischemia can be monitored in the tissue with microdialysis and analysed. The aim of this study is to evaluate cell damage during and after pneumoperitoneum by microdialysis.

**Material and Method:** Two microdialysis catheters were inserted into both cortex and medulla of left kidney after open laparotomy to eight pigs. Continuous microdialysis analysing was performed under standard pressure (16-18 mmHg) for 4 hours and after rapid disafflation.

**Result:** During pneumopeitoneum, Glucose, Lactate and Pyruvate level did not show ischemia pattern and Lactate-Pyruvate Ratio in cortex and medulla gradually decreased. After decompression, Glucose, Lactate, Pyruvate level and Lactate-Pyruvate ratio did not change, but Glycerol level especially in medulla rapidly increased.

**Conclusions:** The changes in glucose metabolism and glyceral level strongly suggested that renal cell damage occurs. This injury is most likely related to hyperperfusion after decompression, or mechanical cell expansion at the point of rapid decompression. Microdialysis is useful tool to monitor the cell damage faster than analyzing peripheral blood.

## S042

**TCF7L2 EXPRESSION IN DIABETIC PATIENTS UNDERGOING BARIATRIC SURGERY**, Rahul Tevar MD,Fred Brody, MD, MBA,Sara Hill BS,Brian Kluk BS,Tim McCaffrey PhD,Sidney Fu PhD, The George Washington University Medical Center
Objective: Bariatric surgery can improve type 2 diabetes in obese patients. However, the physiologic mechanisms of this process remain unclear. Genetic studies have linked polymorphisms of the transcription factor 7-like 2 (TCF7L2) gene with type 2 diabetes. We examined the expression of the TCF7L2 gene product in patients undergoing bariatric surgery.

**Methods:** Extraneous liver tissue was collected from 22 patients (8 diabetic) and snap frozen in liquid nitrogen. Total RNA was extracted from each tissue sample and reverse transcribed into cDNA. TCF7L2 expression was measured using quantitative PCR (qPCR) with oligonucleotide primers specific for the TCF7L2 gene product. The 18S ribosomal gene was used to normalize expression levels. A linear

regression analysis of TCF7L2 was performed using preoperative variables including BMI, age, and HbA1c. Statistical analysis was considered significant at p<0.05.

**Results:** TCF7L2 expression had a significant positive linear relationship with BMI in patients with diabetes or HgbA1c >6.0% (p<0.02). TCF7L2 expression was not significantly correlated with BMI in non-diabetic patients. Finally, no significant correlation was found between TCF7L2 expression and age.

**Conclusions:** Increased expression of TCF7L2 correlates with increased BMI in diabetics undergoing bariatric surgery. These results suggest that the mechanisms of impaired glucose homeostasis in morbid obesity may involve the TCF7L2/Glu-1 signaling pathway. TCF7L2 or its downstream products may be effective as markers or as novel therapeutic targets for diabetes in obesity. Our future studies will examine the relationship between TCF7L2 and BMI in peripheral blood obtained from bariatric patients pre- and post-operatively.

## S043

**IMMUNOHISTOCHEMICAL AND HISTOLOGICAL ANALYSIS OF HOST REACTION TO HEAVY-WEIGHT, REDUCED-WEIGHT, AND POLYTETRAFLUOROETHYLENE-BASED MESHES AFTER SHORT- AND LONG-TERM IMPLANTATIONS**, Yuri W Novitsky MD,Joseph Cristiano BS,Andrew G Harrell MD,H. James Norton PhD,Kent W Kercher MD,B. Todd Heniford MD, Carolinas Medical Center

**Background:** The degree of foreign body reaction is related to the mesh biocompatibility. Exaggerated inflammatory response may lead to excessive scarring with detrimental clinical consequences. Our aim was to characterize the degree of inflammatory change induced by common prosthetic meshes, both short- and long-term.

**Materials and Methods:** Twenty 4x4cm samples each of ePTFE, standard polypropylene(PP), ePTFE with PP(ePTFE/PP), and reduced-weight PP(rPP) were implanted intraperitoneally in 40 rabbits. After 4 and 12 months, mesh/tissue complex samples were sectioned for histologic and immunohistochemical analysis of infiltrating cell types (Masson's trichrome), cellular apoptosis (ELISA) and cellular turnover (Ki-67 mouse monoclonal antibody). Statistics were performed using Kruskal-Wallis and Wilcoxon-Rank Sum tests.

**Results:** In the short-term, the cell apoptosis surrounding PP and ePTFE/PP was significantly higher than either ePTFE or rPP (P<0.01). The amount of Ki-67-positive cells was higher in the PP than ePTFE and rPP groups (p=0.004 and p=0.002). The cell turnover in the ePTFE/PP group was similar to the PP group, but higher than either ePTFE or rPP groups (p=0.007 or p=0.003). In the long-term, the degree of apoptosis was significantly lower in the ePTFE than ePTFE/PP and PP groups. There were no differences between the ePTFE vs rPP or PP vs ePTFE/PP groups in either apoptosis or Ki-67 positivity. When the short and long-term groups were compared, significant reduction in apoptosis was noted in all meshes except for PP. Histologically, the numbers of inflammatory and giant cells were statistically greater surrounding PP and ePTFE/PP meshes.

**Conclusion:** PP-based meshes were associated with more profound inflammatory response, higher cell apoptosis and turnover, indicative of ongoing inflammation and scar remodeling even 1 year after implantation. Overall, exaggerated and persistent host foreign-body response to heavy-weight polypropylene-based meshes indicates poor biocompatibility with potential detrimental clinical sequelae. rPP mesh may have better tissue response due to the reduction in foreign body.
<figure><img src="image_16.png" /></figure>

## S044

**TRANSGASTRIC INSTRUMENTATION AND BACTERIAL CONTAMINATION OF THE PERITONEAL CAVITY**, Jeffrey W Hazey MD, Bradley J Needleman MD, W S Melvin MD, Dean J Mikami MD, Vimul R Narula MD, The Ohio State University Medical Center

**Introduction:** Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a rapidly evolving technique providing access to the peritoneum utilizing an endoscope via a natural orifice. One of the most significant requirements of this technique is the need to minimize the risk of clinically significant peritoneal contamination. We report the bacterial load and contamination of the peritoneal cavity in patients requiring a gastrotomy open to the peritoneum duringouxeny gastric bypass.

**Methods and Procedures:** We prospectively studied 19 patients undergoing laparoscopic gastric bypass. As part of the operative procedure, a gastrotomy was created to perform the gastrojejunostomy. We recorded the patient's PPI utilization preoperatively and sampled gastric contents without lavage. We also sampled peritoneal fluid prior to and after gastrotomy noting the length of time the gastrotomy was open to the peritoneum. Each of the three samples was sent for bacterial colony counts, accounting for dilution with irrigation, and culture with identification of species. Morbidity and mortality were also recorded.

**Results:** Nineteen patients underwent laparoscopic roux-en-y gastric bypass with a mean operative time of 95 minutes. The gastrotomy was open to the peritoneal cavity for an average of 18 minutes. Five of nineteen patients were on ppi's preoperatively resulting in no significant difference in post gastrotomy peritoneal bacterial counts. The average number of colony forming units (CFU) of the gastric aspirate was 7,672 CFU/ml. Peritoneal aspirates obtained for examination prior to creation of a gastrotomy showed no CFU's in 18 of 19 patients. One patient had 167 CFU/ml prior to creation of the gastrotomy. Peritoneal sampling after gastrotomy showed contamination of the abdomen with an average of 24,720 CFU/ml. There was no correlation between the bacterial load in the stomach and peritoneal load after gastrotomy. No patients developed an infectious complication or leak. There was one complication of rhabdomyolysis in a patient with no peritoneal bacterial contamination.

**Conclusions:** Transgastric instrumentation does contaminate the abdominal cavity but pathogens are clinically insignificant due to species or bacterial load.

## S045

**INFECTIOUS COMPLICATIONS OF NATURAL ORIFICE TRANSLUMENAL ENDOSCOPIC SURGERY (NOTES) WITH PERCUTANEOUS ENDOSCOPIC GASTROTOMY (PEG) TUBE CLOSURE: A QUANTITATIVE BACTERIOLOGIC STUDY IN THE PORCINE MODEL**, Michael F McGee MD, Jeffrey M Marks MD, Raymond P Onders MD, Amitabh Chak MD, Michael J Rosen MD, Christine P Williams MD, Judy Jin MD, Steve J Schomisch BS, Jeffrey L Ponsky MD, Case Medical Center, Case Western Reserve University, Department of Surgery, Department of Gastroenterology, Cleveland, Ohio, USA

**BACKGROUND:** Reliable closure of transvisceral defects is a barrier currently limiting NOTES in human practice. PEG tubes have been proposed as means of managing a NOTES gastrotomy while providing chronic enteral access. NOTES PEG closure has not been studied in survival animals, nor have the microbiological implications of NOTES been characterized.

**METHODS:** 19 pigs received gastric lavage with saline, chloramphenicol or no lavage and underwent transgastric NOTES peritoneoscopy. Quantitative cultures were obtained endoscopically at discrete points during each surgery. A sterile foreign body (teflon coated wire) was placed percutaneously under NOTES guidance into the peritoneal cavity and left in place. The gastrotomy was closed with a standard 20-Fr. PEG tube. Animals were followed for 14 days and then underwent sterile laparotomy. Completion cultures for both wire and peritoneal cavity were obtained.

**RESULTS:** 19 animals successfully underwent NOTES and 18 (94.7%) survived the entire 14 day period without observable sequelae. 1 animal died on post-operative day #2 after the PEG tube dislodged. At 14 days, 5 animals (27.8%) demonstrated intra-abdominal abscesses, 7 (38.9%) had positive peritoneal wash cultures, and 10 (55.6%) wires were contaminated on culture. 12 animals (75%) had either abscess, positive peritoneal, or positive wire culture at the end of the study. Infectious complications were not altered by type of gastric lavage or peritoneal bacterial inoculum introduced at time of surgery. Pre-procedural lavage was not effective in completely evacuating gastric succus, as 8 of 13 animals (38.5%) had intra-operative NOTES peritoneal fluid cultures grow in excess of 10^3 CFU/ml of bacteria.

**CONCLUSIONS:** In the pig, PEG closure of a NOTES gastrotomy causes subclinical intra-abdominal abscess formation, and can result in death when the tube is dislodged in the perioperative period. Pre-procedural gastric lavage does not alter the intra-abdominal bacterial burden introduced at time of surgery or subsequent infectious outcomes in the pig model. Infectious complications may represent failure of PEG gastrotomy management, intra-operative seeding and deposition of succus during NOTES, or conditions unique to the pig such as inability to evacuate bezoars, dependent positioning of the PEG, and quadrupedism. These concerning findings necessitate additional studies to determine if porcine models are appropriate and applicable to human subjects in the NOTES setting.

## S046

**DUAL LUMEN NOTES: A NEW METHOD FOR PERFORMING A SAFE ANASTOMOSIS**, Yoav Mintz MD, John Cullen MD, Eric Falor, Mark A Talamini MD, Department of General Surgery, University of California San Diego, CA

**Objective:** Bowel anastomosis is one of the most challenging and difficult tasks to perform during NOTES procedure due to the technical limitations of the endoscopic instruments available. Currently, endoscopic clips, T-bar sutures or cumbersome suturing devices are used. A dual lumen NOTES approach will facilitate bowel resection in a pig model by allowing the use of laparoscopic staplers through the rectum.

**Methods:** An acute study on a 40-kg pig model was performed in the dual lumen NOTES approach. An endoscope was passed into the stomach and was pushed through the stomach wall into the peritoneal cavity following an incision on the anterior wall of the stomach. A 5 mm incision on the anterior part of the rectum was performed under direct vision using the gastric endoscope. A laparoscopic stapling device was then passed through the rectum and into the peritoneal cavity. Following this, a loop of small intestine was transected using both the stapler and the gastric endoscopic instruments. Small enterotomies were made in each bowel stump and the two segments of bowel were loaded onto the stapler using the endoscopic graspers. A communication between the two parts of bowel was created and a final staple load closed the remaining enterotomy and completed the anastomosis. The resected small bowel was then removed through the rectum.

**Results:** Small bowel resection and anastomosis was successfully created using the dual lumen NOTES approach. The stapler was used one more time to close the gastrotomy. At autopsy, intact suture lines were noted at the bowel anastomosis and in the stomach with no evidence of leak from either site.

**Conclusions:** Performing a sutured anastomosis in NOTES is complex and time consuming. Designing flexible staplers that would fit through the endoscope channels is a major engineering challenge and therefore there is a need for another method. The use of stapling devices designed for laparoscopic procedures greatly facilitates gastrointestinal tract operations in NOTES. Using both the upper and lower GI tract as entry sites for natural orifice surgery eliminates some of the current technical limitations of these procedures. Additionally, staple closure of the stomach incision is a convenient and safe method that can be applied in the same manner. Closing the rectal incision seems to be a lesser challenge.
## S047

**SUCCESSFUL CLOSURE OF GASTROTOMY USING BIOABSORBABLE PLUGS IN A CANINE MODEL**, T J Cios BS, K M Reavis MD, D R Renton MD, J W Hazey MD, D J Mikami MD, M T Allemang BS, S S Davis MD, C M Paul BA, W S Melvin MD, The Ohio State University Hospital, Center for Minimally Invasive Surgery

**Introduction:** The repair of gastric perforation commonly involves simple suture closure using an open or laparoscopic approach. An endoluminal approach using prosthetic materials may be beneficial. The role of bioprosthetics in this instance has not been thoroughly investigated, thus we evaluated the feasibility of gastric perforation repair using a bioabsorbable plug and quantified gross and histological changes at the injury site.

**Methods:** Twelve dogs were anesthetized and underwent open gastrotomy. A one centimeter-diameter perforation was created in the anterior wall of the stomach and plugged with a bioabsorbable device. Luminal pH was recorded. Dogs were sacrificed at 1,6,8 and 12 weeks. The stomach was explanted followed by gross and histological examination. The injury site was examined; the relative ability of the device to seal the perforation was recorded, as were post-operative changes. Tissue samples were analyzed for gross and microscopic tissue growth and compared to normal gastric tissue in the same animal as an internal control. A scoring system of -2 to +2 was used to measure injury site healing.

-2 = Leakage present; no tissue ingrowth

-1 = No leakage; minimal tissue ingrowth

0 = Physiologic healing

+1 = Mild hypertrophic tissue ingrowth

+2 = Severe hypertrophic tissue ingrowth

**Results:** In all dogs, the bioabsorbable plug successfully sealed the perforation without leak under ex vivo insufflation. At one week, the device maintained its integrity but there was no tissue ingrowth. Histological healing score was -1. At six and eight weeks, gross examination revealed a healed injury site in all animals. The luminal portion of the plug was completely absorbed. The gross and histological healing score was 0.

**Conclusion:** The application of a bioabsorbable plug results in durable closure of gastric perforation with physiologic healing of the injury site. This method of gastrotomy closure may aid in the evolution of advanced endoscopic approaches to perforation of the GI tract.

## S048

**RELIABLE GASTRIC CLOSURE AFTER NOTES USING A NOVEL PER-ORAL FLEXIBLE STAPLING DEVICE**, Ozanan R Meireles MD, Sergey Kantsevoy MD, Lia R Assumpcao MD, Eric J Hanly MD, Anthony N Kalloo MD, Michael R Marohn DO, Dept of Surgery - Johns Hopkins University School of Medicine, Baltimore, MD

**Introduction:** Among natural orifice transluminal endoscopic surgery (NOTES) approaches, the transgastric route is both the most studied and appears the most promising. However, transgastric NOTES still has important challenges to overcome, including the crucial step of assuring reliable and adequate gastrotomy closure. We report our initial experience with gastrotomy closure using Power Medical's SurgASSIST, a novel, per-oral, flexible, endoluminal automated stapling device investigated in a porcine model of NOTES.

**Methods:** Four adult swine underwent per-oral gastrotomy with transgastric advancement of the gastroscope into the peritoneal cavity. At conclusion of the NOTES procedure, the gastroscope was withdrawn to within the stomach. The SurgASSIST stapler was advanced per-orally into the stomach. Under direct visualization, gastrotomy edges were positioned between the stapler blades using two gastroscope forceps inserted through the working channels. The stapler blades were approximated and the stapler load fired; the stapling device's cutting blade was deployed, transecting

between the two staple lines leaving a linear gastric staple line representing gastrotomy closure, and a small linear piece of gastric tissue which was removed. Integrity of the staple line was assessed with visual inspection. Upper GI xray series was then performed to assess for gastric leakage. All procedures were performed in accordance with an institutionally approved animal care and use protocol.

**Results:** The SurgASSIST stapling device was easily introduced through the oral cavity into the esophagus and gastric chamber. The number of staple loads varied from one to two to obtain complete gastric closure. The resected portion of gastric tissue following staple deployment and transaction revealed continuous, intact staple lines in all animals. Upper GI series demonstrated no gastric leaks.

**Conclusion:** NOTES is feasible and an expanding array of potential applications are being investigated. However, dependable gastric closure is essential for future clinical application of NOTES. The Power Medical SurgASSIST device may provide a simple, secure, reliable, technique for gastric closure following NOTES. The results of this small pilot experiment warrant the performance of a large-scale animal survival study to evaluate the long-term efficacy of SurgASSIST for gastric closure NOTES transluminal surgery.

## S049

**COMPLETE ENDOSCOPIC CLOSURE OF GASTROTOMY FOLLOWING NATURAL ORIFICE TRANLUMENAL ENDOSCOPIC SURGERY (NOTES) USING THE NDO PLICATOR**, Jeffrey Marks MD, Michael McGee MD, Raymond Onders MD, Amitabh Chak MD, Christina Williams MD, Judy Jin MD, Steve Schomisch, Jeffrey Ponsky MD, Case Western Reserve University

**Background:** The NDO Plicator is a device developed for endoscopic treatment of gastroesophageal reflux disease (GERD) by approximating tissues together with a double pledgedt u-stitch. It was theorized that this device may facilitate transgastric NOTES, as closure of the transgastric defect remains a key component for advancement of this new technology.

**Methods:** A standardized 12 mm gastrotomy was created endoscopically in 4 pigs with a combination of needle knife cautery and balloon dilation. As the endoscope was removed, a Savory soft-tipped wire was introduced into the stomach and the NDO Plicator was subsequently advanced over the wire. Each defect was identified and the device was positioned. If necessary, the Plicator's tissue grasper was used to hold the superior aspect of the gastrotomy and bring the opposed borders of the defect within the jaws of the device. The device was fired three times, leaving three pledgedt suture bundles to close the gastric defect. Following closure, each animal was explored and the integrity of closure was assessed. Animals underwent in vivo contrast fluoroscopy and ex vivo burst pressure testing studies to assess leakage at the closure site.

**Results:** The first animal was used to test feasibility, refine techniques, and develop a standard procedure. Of the next three animals studied, all showed complete sealing of the gastrotomy site without evidence of contrast extravasation on multi-planar fluoroscopic imaging. Each stomach was excised, submerged under water, and subjected to a presurized air leak test. No air leaks were noted until pressures exceeded 55 mmHg.

**Conclusion:** This study supports the use of the NDO Plicator for closure of standardized gastric defects in a porcine model. In addition to closing NOTES gastrotomies, the NDO Plicator may be a particularly useful tool in obtaining complete closure of gastric perforations, anastomotic leaks, and performing stomal reduction following gastric bypass procedures. The mechanical properties of a closure are not the only factor in determining if a leak will develop. Tissue apposition, ischemia, and tension are important factors that are not easily or reliably measured. The physiologic relevance of gastric bursting pressure is not known; therefore corollary studies with longer term evaluation in animals are necessary prior to proceeding to clinical trials.
<figure><img src="image_17.png" /></figure>

## S050

**OBJECTIVE OUTCOME ANALYSIS OF CURRENTLY AVAIL-**
**ABLE GASTRO-ESOPHAGEAL REFLUX DISEASE (GERD)**
**TREATMENTS., Richard Nguyen DO, Yasser Youseff MD, Joan**
**Kiser RN, William O Richards MD, Alfonso Torquati MD,**
**Vanderbilt University**

Despite the endoscopic treatment for GERD has been avail-
able in the last 5 years, there are no studies that compare
objective outcome of these procedures with the gold stan-
dard therapies: laparoscopic Nissen fundoplication (LF) and
proton-pump inhibitors (PPI). The aim of the study is to
evaluate if these new endoscopic techniques have compar-
able efficacy in distal esophageal acid exposure control.

**Methods:** Under IRB approved protocols, 57 patients with pH-data proven GERD were included in cross-sectional study after GERD treatment. A 24-hour pH study was performed in 13 patients with on-going BID PPI therapy, in 10 patients after LF fundoplication, 10 patients after endoscopic plication (NDO Plicator) and in 24 patients after endoscopic radiofrequency treatment (Stretta procedure). Tracings were analyzed for distal esophagus acid exposure.

**Results:** As shown in the table, patients after LF and with ongoing PPI treatment had a significant lower distal esophageal acid exposure (P<0.05 vs. Plicator and RF) and lower Johnson-DeMeester score (P<0.05 vs. Plicator and RF). Furthermore, LF and PPI treatment were more effective in achieving a normal pH exposure in GERD patients (P<0.05 vs. Plicator and RF).

<table><thead><tr><td>Pt. with pathol</td><td>% time pH&lt;4.0</td><td>Johnson-DeMeest</td></tr></thead><tbody><tr><td>LF (n=10)</td><td>0/10 (0)</td><td>1.2±0.9 5.9±5.0</td></tr><tr><td>PPI (n=13)</td><td>2/13 (15)</td><td>2.5±4.1 12.2±21.1</td></tr><tr><td>Plicator (n=10)</td><td>6/10 (60)</td><td>5.1±3.4 28.9±19.1</td></tr><tr><td>RF (n=24)</td><td>15/24 (62.5)</td><td>5.4±3.5 29.5±19.9</td></tr></tbody></table>

Results of Ph study after treatment

**Conclusion:** Currently, laparoscopic Nissen fundoplication and PPI therapy still represent the best therapeutic approaches in patients with GERD in terms of objective outcome.

## S051

**FLANK APPROACH VERSUS ANTERIOR SUBMESOCOLIC**
**ACCESS IN LAPAROSCOPIC LEFT ADRENALECTOMY: A**
**RANDOMIZED TRIAL, Mario Guerrieri MD, Francesca Crosta**
MD,Maddalena Baldarelli MD, Giovanni Lezoche MD,Angelo
De sanctis MD,Roberto Campagnacci MD,Emanuele Lezoche
MD, General Surgery and Surgical Methodology Unit,
University of Ancona, Italy; 2nd Surgical Institute, "La
Sapienza" University, Rome, Italy

**Aim:** The most frequently access performed by laparoscopy to adrenal gland is the flank approach. Aim of the present study is to compare the results of two different approach to adrenal gland in a randomized trial: anterior submesocolic access vs flank in laparoscopic left adrenalectomies.

**Patients and methods:** Twenty four cases were treated by flank intraperitoneal approach (group A) and 23 by submesocolic transperitoneal approach (group B). BMI, operative time (total and from the start of the skin until adrenal vein closure), hospital stay, tumour size, definitive histology between the two approach were analysed.

**Results:** There were not conversions to open surgery neither major complications. Mean BMI was similar between two groups. Mean operative time was 75 min (range 50-140) vs 61,75 (range 40-130) between group A and B, respectively (p<0,05). Mean operative time from the start of the skin until adrenal vein closure was 42 min (range 34-57) vs 21 (range 16-27) between group A and B, respectively (p<0,05). Mean hospital stay was 3,2 days vs 2,1 between group A and B, respectively (p<0,004). Mean tumor size was similar between group A and B: 3,6 (range 1,5-6,5) vs 3,8 (range 2-6), respectively. Definitive histology between group A and B were: Cushing adenoma (6 vs 3), Conn adenoma (5 vs 6), pheochromocytoma (3 vs 9), Incidentaloma (7 vs 4). Moreover 1 myelolipoma, 1 metastases and 1 adreno-

genital adenoma were observed in group A and 1 carcinoma was observed in group B.

**Conclusions:** Submesocolic approach provides a significantly shorter operating time and hospital-stay. The identification and early closure of the adrenal vein with minimal gland manipulation resulted the main benefit of this approach.

## S052

**MORBIDITY AND COMPLICATIONS FOLLOWING**
**TRANSANAL ENDOSCOPIC MICROSURGERY: A SINGLE**
**SURGEON'S TWENTY FIVE YEARS EXPERIENCE, Lee E**
**Smith MD, Chadi T Abouassaly MD,**
**Washington Hospital Center**

Transanal endoscopic microsurgery (TEM) has been advocated as an alternative to radical surgery for tumors of the rectum in patients with benign or T1N0M0 carcinomas or as palliation in high risk patients. The purpose of this article is to review our complications with TEM. From 1991-2006, we treated 183 patients with TEM. Indications were adenoma in 94, rectal cancer in 37, malignant polyp site in 30, carcinoid in 13, and palliation in 9. Follow up ranged from one month to 125 months with an average of forty two months. The average level of lesions in rectum was 8.27 cm. The adenoma group had the largest average diameter with carcinoid and malignant polyp site being the smallest (3.65, 1.35, 1.39 cm respectively). One patient died of an ischemic colon within one month of surgery. Twenty five patients (13.6%) had complications. The most frequent morbidity was urinary retention in 6 patients. Two patients had a significant rectal bleed that occurred after they were discharged and necessitated hospital readmissions. One patient complained of short term musculoskeletal pain which was attributed to intra-operative positioning. Five patients had complications related to anesthesia. Two patients had perforation into the peritoneum requiring laparotomy; both were in the adenoma group. One patient developed a recto-vaginal fistula. Three patients were febrile post-operatively and were treated with antibiotics empirically. One patient developed C-Difficile colitis. The group that underwent TEM for carcinoid, had no complications and had the smallest diameter of lesion excised. The rest of the groups had no significant difference in rate of complications.

Average length of hospital stay was 0.5 days, with a range from zero to seven days. TEM is a safe and well tolerated procedure with few major complications, even in a high risk population. It is a good option for T1N0M0 carcinomas, benign lesions and high risk patients.

## S053

**PROVIDER VOLUME IMPACTS IN-HOSPITAL MORTALITY**
**FOLLOWING GASTRIC BYPASS SURGERY, Jennifer L Denne**
MD,Yangchun Du MS,loannis Raftopoulos MD,Frank
D'Amico PhD,Anita Courcoulas MD, University of Pittsburgh
School of Medicine, Duquesne University Department of
Statistics

Initiatives such as pay for performance and center of excellence designation offer great promise for improving surgical quality. In addition, there is increasing recognition that surgical outcomes following complex procedures vary by provider, both surgeon and hospital. Gastric bypass surgery is one such procedure that is the subject of increasing scrutiny as it relates to outcomes and has become a popular target for quality-based selective contracting. This study explores the relative importance of surgeon and hospital volume on in-hospital mortality following gastric bypass surgery in a large population-based and geographically diverse sample. Using information from five states' discharge databases for 2001-2003, we examined mortality among 49,111 patients who underwent gastric bypass procedures. There were 122 in-hospital deaths among 49,111 cases (0.25%) over the three-year period. Hospital volume was grouped into "low", "medium", and "high" volume institutions, each containing approximately one third of the total number of patients treated. Surgeon volume was categorized based on clinically relevant numbers of cases per-
<figure><img src="image_18.png" /></figure>

formed (< 150 cases, 151-584 cases, and > 585 cases per surgeon) over the three-year period. Model adjusted mortality rates for "low" to "high" volume hospitals were 0.23%, 0.21%, and 0.31%, respectively (p = 0.60). In contrast, surgeon volume was strongly, and inversely, related to operative mortality (p<0.01) with rates of 0.48% (< 150 cases), 0.27% (151-584 cases), and 0.01% (> 585 cases). The most common in-hospital, post-operative complications were respiratory in nature, followed by cardiac, bowel obstruction, and bleeding. Of those patients who had infection, peritonitis, fascial wound disruption, or acute renal failure, eight to 12% of them went on to die during that hospitalization. In-hospital mortality following gastric bypass is significantly lower when performed by high-volume surgeons. The volume level of the hospital did not have the same effect on outcome. The finding that the volume-outcome effect is mediated by surgeon alone, along with the early complication profile, indicates that this may be due to a higher technical, operative and early complication rate among inexperienced surgeons. These results can be used to help define opportunities to improve care and imply that increasing the individual surgeon's volume under mentorship can save lives, further contributing to improvement in surgical quality.

## S054

**SIMULATED LAPAROSCOPIC OPERATING ROOM CRISIS: APPROACH TO ENHANCE THE SURGICAL TEAM PERFORMANCE**, Kinga A Powers MD, Scott T Rehrig MD, Noel Irias, Hedwig A Albano RN, David M Feinstein MD, Anna C Johansson PhD, Stephanie B Jones MD, Andrew Malinow PhD, Donald W Moorman MD, John B Pawlowski MD, Daniel B Jones MD, Beth Israel Deaconess Medical Center, Harvard Medical School

**OBJECTIVE:** Diminishing human error and improving patient outcomes is the goal of task training and simulation experience. The Fundamentals of Laparoscopic Surgery (FLS) is a validated tool to assess technical laparoscopic skills. We hypothesize that performance in a crisis depends on technical skills and team performance. We developed a high fidelity crisis simulation model and evaluated its face and construct validity. Reliability of measures of individual provider's technical and team performance were also tested.

**METHODS:** Conducted in our mock endosuite, the scenario assessed FLS certified surgeon experts (n=5) and not FLS certified novices (n=5). Performance was assessed using validated procedure-specific rating scales. Objective outcome measures were: time to diagnose bleeding (TD), to inform the team (TT), to convert to open (TC). Welch's t-Test, ANOVA and Cronbach's coefficient alpha were used for data analysis.

**RESULTS:** Median Score for Face Validity was 4.2, 4.4, 4.6 (maximum=5) for FLS, non-FLS and nursing groups respectively, with an inter-rater reliability of 93%. Although no difference was observed in Veress safety (VS) and laparoscopic equipment set up (SU) (p>0.05), there was a significant difference between the two groups in their overall technical and non-technical abilities (p<0.05), especially in identifying bleeding (IDB), controlling bleeding (CB), team communication (TCom) and team skills. There was a trend, towards a difference between the two groups for TD, TT and TC. While experts controlled bleeding in a shorter time they persisted longer laparoscopically.

<table><thead><tr><th rowspan="2">group</th><th colspan="4">TECHNICAL (%)</th><th colspan="4">NON-TECHNICAL (%)</th></tr><tr><th>VS</th><th>SU</th><th>IDB</th><th>CB</th><th>Overall</th><th>T Com</th><th>T Skills</th><th>Overall</th></tr></thead><tbody><tr><td>FLS</td><td>96.2<br>≥2.5</td><td>93.7<br>≥7.5</td><td>86<br>±11.1*</td><td>91<br>±17.5*</td><td>91<br>±17.5*</td><td>94<br>±4.5*</td><td>86<br>±6.2*</td><td>89<br>±5.9*</td></tr><tr><td>NON</td><td>79<br>±18.3</td><td>80.0<br>≥7.9</td><td>13<br>±18.9</td><td>43<br>±25.6</td><td>46<br>±21.6</td><td>56<br>±12.8†</td><td>53<br>±9.3</td><td>51<br>±14.8</td></tr></tbody></table>

All data mean ± SD, P < 0.05 *

**CONCLUSIONS:** Our evidence suggests that face and construct validity has been established for a laparoscopic simulation in a mock endosuite. Technical and non-technical performance discrimination was observed between novices and experts. This innovative multidisciplinary simulation is aimed at improving error/problem recognition and initiation of appropriate and safe responses by surgical teams.

## S055

**TIMING OF LAPAROSCOPIC CHOLECYSTECTOMY FOLLOWING EMERGENCY ADMISSION WITH ACUTE BILIARY DISEASE**, Gerald G David, Ali A Al-Sarira, Simon L Singer, David J Corless, Mark Deakin, John P Slavin, Department of General Surgery, Leighton Hospital, Crewe. United Kingdom. Department of General Surgery, University Hospital of North Staffordshire, Stoke-on-Trent. United Kingdom.

**Introduction.** Early laparoscopic cholecystectomy (LC) is considered to be safe and efficacious in the management of acute biliary colic or cholecystitis. If LC is performed after 72 hours of symptom onset the conversion rate was thought to be higher. We set out to analyse the timing of LC and its relation to conversion rate following emergency admission with acute biliary disease.

**Methods.** Hospital Episode Statistics (HES) data for the year 2003 - 04 was obtained from the Department of Health and exported to an access database for analysis. All patients admitted as an emergency with gall stone disease as identified by the International Classification of Diseases (ICD) code - 10th revision K80 were included in our analysis. Operative codes for laparoscopic and lap converted to an open cholecystectomy were used to identify patients undergoing surgery.

**Results.** Thirty two thousand one hundred and five patients were admitted 36,442 times as an emergency with acute gall bladder disease in England between April 2003 and March 2004. The male to female ratio was 1:2 and the median age at presentation was 59 years (Inter quartile range (IQR) 42 - 72 years). Four thousand and eighty three (13.34%) patients underwent an emergency cholecystectomy during their first emergency admission. The median number of days between admission and operation was 3 (IQR 1-6). Three thousand (70.05%) of these were attempted laparoscopically. Two hundred and ninety eight LCs were converted to an open cholecystectomy (Conversion rate of 9.93%). When the conversion rate was further analysed over the first week following admission, there was no statistically significant difference observed on any particular day (p value 0.35). The median post op stay following a LC was 2 days (IQR 1 - 4 days) and was significantly lower compared an open cholecystectomy or a laparoscopic converted to an open cholecystectomy when the median post op stay was 6 days (IQR 3-10 days), p value <0.001.

**Conclusions.** The conversion rate for an emergency LC remains around 10% during the first week following an emergency admission with acute biliary disease and is not increased after 72 hours. Successful laparoscopic cholecystectomy is associated with a reduced post operative stay.

## S056

**THE IMMEDIATE REOPERATION OF T1B INCIDENTAL GALLBLADDER CARCINOMA- A CONTROVERSY DEBATE ABOUT THE POSSIBLE IMPROVEMENT OF THE PROGNOSIS AND ABOUT GETTING A DEFINITE STAGING.**, Vittorio Paolucci PhD, Thorsten Goetze PhD, Clinic for general-, abdominal- and minimally invasive surgery

**Introduction:** The immediate reoperation after a cholecystectomy for an incidental gallbladder carcinoma is discussed controversy.

For a T1 tumour a cholecystectomy is enough. For T2 and more advanced stages an immediate reoperation is permitted according to the guidelines of German Society of Surgery.

The rate of positive lymph nodes is up to 46% in the T2 stage.

In which T-stage such a reoperation should be undertaken is discussed controversy in the international literature. Some authors recommend a reoperation in case of T1b-stage and improve the 5 year survival from 60 to 100%, because the rate of positive lymph nodes is up to 16% and the lymphatic, venous and perineural infiltration is up to 50% according to the literature.

Others recommend a reoperation only when the margins are positive or when there is subserosal invasion > 2mm. The question is, if T1b tumours do profit from a reoperation
<figure><img src="image_19.png" /></figure>

or if this operation is only an additional lethality, the same question for T3 and T4 tumours.

**Material and method:** To obtain data we are using Register of incidental gallbladder carcinoma of the German Society of Surgery.

**Results:** 441 cases of incidental gallbladder carcinomas are registered.

In 68 patients with T1- tumour there was no reoperation.

In 23 patients with T1- tumour there was a reoperation.

There is a prognostic advantage for T1- tumours with a reoperation.

In 115 patients with T2- tumour there was no reoperation.

In 85 patients with T2- tumour there was a reoperation.

The Kaplan- Meier graph for T2- tumours shows a significant prognostic advantage for T2- tumours with reoperation.

Graph 3 and 4 shows no better survival for T3 and T4- tumours after a reoperation.

**Discussion:** There is a survival benefit for the reoperated T1b tumours and a significant better survival for T2- tumours after an immediate reoperation (log- rank < 0,05).

For T3/4- tumours there seems to be no prognostic benefit.

Gallbladder cancer is a very aggressive tumour and the following outcome is not clear, so according to the authors an immediate reoperation for patients with gallbladder cancer above all in the early stages should be proclaimed, regarding the morbidity and mortality.

Without a radical resection it is almost impossible to make definite statement concerning the nodal status and to get exact staging of the patient to estimate the prognosis.

## S057

### INTRAOPERATIVE ERCP FOR THE TREATMENT OF RETAINED BILIARY STONES, Avraham Belizon MD, Valentine

Nfonsam MD, Bernard Stark MD, Amit Joshi MD, Gary

Gecelter MD, Long Island Jewish Medical Center

We have previously demonstrated the feasibility of combined laparoscopic cholecystectomy (LC) and intraoperative ERCP for the management of retained common bile duct (CBD) stones. This larger scale study evaluates the combined procedure in more detail and compares it to the results of alternative management options reported in the literature.

**Methods:** All pts at a single institution that underwent a combined LC/ERCP between Jan 93 and July 06 were identified using a computerized operating room database. All pts had either an intraoperative transcystic cholangiogram positive for retained CBD stones or clear preoperative evidence of choledocholithiasis. Charts were reviewed for age, length of stay, morbidity, mortality, ERCP results, and postoperative course.

**Results:** A total of 287 pts were identified during the time period under investigation. The mean age was 59 years. 275 pts (96%) underwent successful combined LC/ERCP. All 275 pts underwent successful stone extraction and endoscopic sphincterotomy. In 8 patients ERCP was unable to be performed and subsequently necessitated either an open or laparoscopic CBD exploration. 4 pts underwent negative ERCP. Overall morbidity was 12% among all pts and 10% among pts with successful ERCP. 8 pts (2.7%) developed cystic duct leaks (2 were recognized during ERCP and underwent stent placement, the remaining 6 necessitated repeat ERCP and stent placement postop), 4 pts (1.4%) developed symptomatic instrumental pancreatitis, 16 pts (5.6%) developed asymptomatic postoperative hyperamylasemia, 2 (0.7%) pts developed a postoperative collections, and 3 pts (1%) had a prolonged hospital stay secondary to a postoperative ileus that resolved with conservative management.

Median op time for the combined procedure was 149 min.

Median length of hospitalization was 2.8 days and the median postoperative hospitalization was 2.1 days. There were no mortalities.

**Conclusion:** We continue to show that combined LC/ERCP is effective management for the treatment of retained CBD stones. In addition, the combined procedure eliminates the need for unnecessary ERCP in the absence of a positive cholangiogram, and obviates the need to return to the OR when postop ERCP is technically impossible. Although fur-

ther study is necessary our results seem to demonstrate distinct advantages with the combined procedure both in regards to LOS, mortality, and morbidity when compared to results reported for pre or postop ERCP and CBD exploration.

## S058

### INCIDENCE OF RESIDUAL CHOLEDOCHOLITHIASIS AT THE TIME OF LAPAROSCOPIC CHOLECYSTECTOMY IN PATIENTS HAVING UNDERGONE PREOPERATIVE ERCP,

Richard A Pierce, Sreenivasa Jonnalagadda MD, Jennifer A

Spitler MD, Deron J Tessier MD, Jane M Liaw MD, Shelly C

Lall MD, Lora M Melman MD, Margaret M Frisella RN, Laura

M Todt BS, Michael Brunt MD, Valerie J Halpin

MD, Christopher Eagon MD, Brent D Matthews MD,

Department of Surgery and Medicine, Washington

University, Saint Louis, Missouri

**Introduction:** The purpose of this study is to determine the incidence of residual common bile duct (CBD) stones after preop ERCP for choledocholithiasis and to evaluate the utility of performing routine intraoperative cholangiography (IOC) during laparoscopic cholecystectomy (LC) in this patient population.

**Methods:** All patients who underwent preop ERCP and interval LC with IOC from 5/96-12/05 were reviewed under an IRB-approved protocol. Data collected included all radiologic imaging, laboratory values, clinical and pathologic diagnoses and results of preop ERCP and LC with IOC. Statistical analysis and significance (p<0.05) was determined using contingency tables with Fisher's Exact Test.

**Results:** A total of 227 patients (M:F 72:155) with a mean age of 51.9 years ± 20.2 underwent preop ERCP for suspicion of CBD stones. Of these patients, 118 (52.0%) were found to have CBD stones while 109 (48%) had a negative ERCP. In the 118 patients with CBD stones, 22 (20.8%) had CBD stones diagnosed on IOC during LC. However, 2 patients had residual stones on completion cholangiogram after preop ERCP and were considered to have retained stones. Therefore, 20 (16.9%) patients overall were diagnosed with interval passage of stones or false negative preop ERCP. There was no correlation (p>0.05) between an increased incidence of CBD stones on IOC and a longer time interval between ERCP and LC, performance of sphincterotomy, incidence of cystic duct stones or pathologic diagnosis of cholelithiasis. In the 109 patients without CBD stones on preop ERCP, 9 patients had CBD stones on IOC during LC, an 8.3% incidence of interval passage of stones or false negative preop ERCP. Similar to the other cohort, there was no correlation (p>0.05) between an increased incidence of CBD stones on IOC, a longer time interval between ERCP and LC, performance of sphincterotomy, incidence of cystic duct stones, pathologic diagnosis of cholelithiasis or the performance of a completion cholangiogram during preop ERCP.

**Conclusions:** The incidence of residual CBD stones or interval passage of stones on IOC during LC after a preop ERCP has documented CBD stones is 16.9%. There is an 8.3% incidence of CBD stones when a preop ERCP is performed for presumptive CBD stones and fails to find any. Although the morbidity of residual CBD stones after preoperative ERCP is not known, the routine use of IOC should be considered in patients with CBD stones on preop ERCP undergoing an interval LC.

## S059

### LAPAROSCOPIC ULTRASOUND AS THE PRIMARY METHOD OF ROUTINE BILE DUCT IMAGING DURING LAPAROSCOPIC CHOLECYSTECTOMY, Kyle A Perry MD, Jonathan A Myers

MD, Daniel J Deziel MD, Rush University Medical Center

**Background:** Intraoperative fluorocholangiography (IOC) has been the standard method of bile duct imaging during cholecystectomy. Laparoscopic ultrasound (LUS) has been evaluated as a possible alternative, but has been used less frequently. We examined the evolving use of these modalities to assess the relative utility of LUS as the primary method for routine bile duct imaging in laparoscopic cholecystectomy (LC).
<figure><img src="image_20.png" /></figure>

**Methods:** We performed a retrospective analysis of a prospective database containing 396 consecutive LC performed by a single attending surgeon in an academic medical center between 1995 and 2005.

**Results:** Intraoperative bile duct imaging was performed in 94% of 396 consecutive LC performed for cholelithiasis. IOC was performed in 239, LUS in 236, and both modalities were utilized in 104 cases. Fifty-five patients (13%) had choledocholithiasis. LUS identified common bile duct stones (CBDS) in 3% of patients without any preoperative indicators of CBDS, and in 10% of patients with one or more indicators. LUS had a PPV of 100%, NPV of 99.6%, sensitivity of 92.3%, and specificity of 100% for the detection of CBDS. In addition to detecting CBDS, LUS identified clinically significant bile duct anatomy in 6% of patients. In 1995, LUS was used in 20% of cases whereas by 2005, it was utilized in 97% of cases.

**Conclusions:** With moderate experience, LUS can become the primary routine imaging modality for evaluation of the bile duct in LC. It is as reliable as IOC for the detection of choledocholithiasis. In addition LUS can facilitate the identification of bile duct anatomy during difficult dissections. Based on this experience, LUS is currently used in 97% of cases, and is the sole imaging modality in 75%.

## S060

### LAPAROSCOPIC COMMON BILE DUCT EXPLORATION CAN BE SAFELY PERFORMED BY TRAINEES, Matthew G Tutton MD, Tan Arulampalam MD, Roger W Motson MD, Colchester General Hospital

**Introduction:** A recent Cochrane review has shown that laparoscopic cholecystectomy with common bile duct (CBD) exploration is at least as safe as pre- or post-operative ERCP for clearing CBD calculi. Laparoscopic CBD exploration avoids many of the complications of ERCP and has the advantage of being performed as one definitive procedure. We aimed to evaluate the outcome of laparoscopic CBD exploration carried out by senior trainees compared to an experienced consultant.

**Methods:** During a 15 year period 235 (161 female) consecutive cases of laparoscopic CBD exploration were prospectively analysed. All patients underwent a standard 4 port technique and operative cholangiogram. Patients demographics, operative-techniques and success of CBD clearance, and complications were analysed.

**Results:** The mean age of patients undergoing laparoscopic CBD exploration was 61 years (range 19-94 years) with 35% being performed as an emergency. 187 (79%) of CBD explorations were performed by one consultant and 48 (21%) by trainees. Calculi were successfully cleared in 141 (90%) and 43 (94%) respectively. The surgical approach was by a tranascystic route in 102 (55%) and 21 (44%) respectively with a choledochotomy used for all other cases. The mean operating time was 136 minutes in the consultant group versus 158 minutes in the trainee group (p=0.02; Mann Whitney U-test). There was one death in the consultant group with 14 (7%) patients having complications and 5 (10%) complications in the trainee group. There was no significant difference in CBD clearance rate, surgical approach and complication rate between consultant and trainees (Fisher's exact test).

**Conclusion:** Laparoscopic CBD exploration is a safe procedure both in consultant and trainee hands with an excellent clearance rate and an acceptable complication rate. In order to provide a one-stop procedure and optimum management for gallstones and clearance of CBD calculi adequate provision of training is required.

## S061

### PRESERVING THE SPLEEN DURING LAPAROSCOPIC DISTAL PANCREATECTOMY- MAIN VESSEL PRESERVATION VERSUS SHORT GASTRIC VESSELS ALONE, Craig J Taylor
MD, Nicholas O'Rourke MD, Leslie Nathanson MD, George Hopkins MD, Royal Brisbane Hospital, Brisbane Queensland Australia

**Background:** Preservation of the spleen is desirable because of important immunological and haematological functions

and can frequently be performed in laparoscopic distal pancreatectomy (LDP). This may be achieved by main splenic vessel preservation (SVP) or through continued perfusion from Short Gastric (SG) vessels alone following excision of the splenic vessels with the distal pancreas as described by Warshaw.

**Method:** The two methods were evaluated through a multicentre retrospective study together with a review of the published literature.

**Results:** 46 consecutive LDP were performed between 1996-2006, with splenic preservation in 14 cases. This was achieved by SVP in 9 cases, and by SG in 5. Mean operative time was shorter (155 vs 205 mins) for SG. Two patients (40%) in the SG group developed infarcted inferior splenic poles (managed conservatively) whilst no splenic complications occurred in the SVP group. The rate of pancreatic fistula (15%) and other non-splenic complications was the same. Overall SVP was more tedious, and virtually impossible if chronic pancreatitis existed.

A total of 153 spleen-preserving LDP were identified from the literature. SVP was performed in 129 (86%) and was associated with significant intra-operative bleeding in 14%. Post-operative splenic complications (infarction or abscess) occurred in 29% of the SG group with over half of these requiring unplanned splenectomy. No post-operative splenic complications occurred in the SVP group. Mean operative duration was 29 mins longer for SVP.

**Conclusion:** Despite taking longer and carrying a potential risk of greater blood loss, SVP is generally preferred over SG because of the moderate risk of post-operative splenic complications.

## S062

### RESULTS OF LAPAROSCOPIC LIVER RESECTION: RETROSPECTIVE STUDY OF 60 PATIENTS., Hitoshi Inagaki
MD, Tsuyoshi Kurokawa MD, Tadashi Yokoyama MD, Manabu Kikuchi MD, Yasuhisa Yokoyama MD, Toshiaki Nonami, Department of Surgery, Yokoyama Hospital for Gastroenterological Diseases, Nagoya, Japan.

**Introduction:** Although an increasing number of reports and publications have dealt with the laparoscopic approach to liver resection, this procedure remains uncommon, and its feasibility, safety and effectiveness are still not established. There are only some reports which prove some advantages on postoperative recovery.

**Aims & Methods:** We clarified our experiences in laparoscopic liver resection mainly from the aspects of safety and effectiveness. We report here operative method, blood loss, operative time and complications in 60 patients who underwent laparoscopic liver resection in our hospital from Dec. 1997 to Jul. 2006.

**Results:** Seventeen patients had cirrhosis. Tumors 2.9 cm in diameter ranging from 1.5 to 5.0 cm were located in every liver segment except segment I. Liver resection was anatomical in 11 patients; lobectomy in 3 patients, and lateral segmentectomy in 8 patients. Non-anatomical resection was performed in 49 patients. Operative time avaraged 2107)98 minutes. Blood loss was 4467)656 g. Hand-assisted laparoscopic surgery was required in 26 patients (43.3%). Operative complications occurred mainly in our early cases. They included 3 patients (5%) with operative bleeding, 2 of them with conversion to laparotomy. Postoperative complications occurred in 8 patients (13.3%): 2 biliary leakage, 4 abscess at cutoff stump of liver, 1 port-site bleeding and 2 surgical site infections. The mean hospital stay was 17 days. There were no complications in our late cases.

**Conclusions:** The laparoscopic approach for liver tumors is feasible, if the indication is strictly selected. Its safety is dependent on surgical experience and technology availability.
<figure><img src="image_21.png" /></figure>

## S063

**LAPAROSCOPIC LIVER RESECTION FOR HEPATOCARCINOMA**, Ibrahim Dagher MD,Alessio Carloni MD,Panagiotis Laina MD,Ariana Boschetto,Dominique Franco, Antoine Beclere Hospital, PARIS

**INTRODUCTION:** Unique small hepatocarcinomas (HCC) are still an indication to partial liver resection when transplantation is not indicated. Anatomical resections are recommended for carcinological reasons. The laparoscopic mini invasive approach should minimize hepatic and parietal injury and consequently decrease the risk of liver failure and ascites. However the carcinologic results of this approach are still uncertain.

**AIMS & METHODS:** The aim of this work was to evaluate the short and midterm results of laparoscopic liver resections for HCC. Between 1999 and 2005, 30 laparoscopic liver resections were performed for HCC. The tumour mean size was $3.7 \pm 2$ cm (range: 1.5 to 7 cm). The patients mean age was $65 \pm 9$ years. 22 patients had cirrhosis (21 Child A and one Child C). Patients were followed up post operatively every four months with a CT scan and áFP measurement. Mortality, morbidity, recurrence and survival rates were analyzed.

**RESULTS:** There were Thirteen unisegmentectomies, 9 bisegmentectomies, 1 trisegmentectomy, 2 right hepatectomies and 5 atypical resections. Operative time was 212 ± 89 minutes. Conversion to laparotomy was required in 3 patients (10%) for continuous although moderate bleeding during transection. The mean blood loss was 522 ml and 5 patients (17%) required blood transfusion. The mean surgical margin was 11 mm ($> 5$ mm in 23 patients). The mean hospital stay was 7.4 days. One cirrhotic patient (Child C) operated for a partially ruptured tumour of the left lobe died of liver failure. No ascites and no transient liver failure occurred in the other 21 cirrhotic patients. During a mean follow-up of 2 years, 11 patients (37%) had recurrence within the liver. Two-year overall and disease-free survival rates were 77% and 63%, respectively. None of the patients had peritoneal carcinomatosis or trocar site deposit during follow-up.

**CONCLUSION:** Laparoscopic liver resection for HCC is feasible and well tolerated. The mid term survival and recurrence rates are similar to those observed after laparotomy.

## S064

**WIRELESS LAPAROSCOPIC ENDOSURGERY**, Per-Ola Park MD,Paul Swain MD,Sandy Mosse PhD,Keiichi Ikeda MD,Maria Bergström MD,Michael Kochman MD, Imperial College, London, University College Hospital, London, Sahlgrenska University Hospital/Ostra, Gothenburg, Sweden, University of Pennsylvania

**Background:** Autonomous miniature wireless laparoscopes might be valuable during intra-abdominal endosurgery. They might add extra images from different angles during selected otherwise conventional laparoscopic procedures. Their use during transgastric endosurgery or single port endosurgery might allow all the available space for access to be used for therapy. Remote methods of camera manipulation and attachment to removable intra-abdominal supporting structures need to be developed. Aim: 1: To acquire wireless intra-abdominal video. 2: To test new radio-controlled RC methods to manipulate intra-abdominal cameras. 3 To study methods using motors and shape memory alloys to perform tasks during NOTES and intra-abdominal surgery.

**Methods:** Wireless capsule endoscopes WCE (27 x 11 mm) acquiring images at 2, 7 and 14 frames per second (Given Imaging - SB and ESO) were used for laparoscopic imaging. Radio controlled servos, motors and shape memory alloy muscle wires were used to manipulate autonomous capsule endoscopes in the peritoneal cavity. WCE were introduced into the peritoneal cavity through trocars or transgastric incisions. Capsule video-images were acquired with a real-time video viewer.

**Results:** This study acquired the first wireless laparoscopic images of intra abdominal organs including gallbladder,

pancreas. It gave close up views of the cystic duct during transgastric gallbladder dissection. Subdiaphragmatic structures difficult to view using rigid laparoscopic instruments were imaged. Internal camera stabilization used moveable candelabra and tripods. RC manipulations used up-down movement with small motors and rotation using servos. New methods of wire guided and wheel based traction within the abdominal cavity were studied. Sutured attachments to the peritoneal cavity of wireless capsule laparoscopes were successful. Wireless imaging of biliary manipulations were achieved without conventional laparoscopes. WCE with two imagers passed through transgastric incisions allowed views of both sides of the gastric incision during suturing procedures.

**Conclusions:** Autonomous wireless laparoscopy was probably performed for the first time. Spatial separation of imaging and therapeutic functions of laparoscopic or transgastric surgery may carry advantages for patients. New RC manipulations of intraperitoneal capsules were performed. Servos, motors, shape memory metal springs were used to alter the autonomous miniature wireless laparoscope by remote control.

## S065

**RESULTS OF A NEW METHOD FOR STOPPING ACUTE BLEEDING FROM ESOPHAGEAL VARICES: IMPLANTATION OF A SELF-EXPANDING STENT**, Jörg Zehetner MD,Andreas Shamiyeh MD,Wolfgang Wayand MD,Rainer Hubmann MD, Ludwig Boltzmann Institute for Operative Laparoscopy, II. Surgical Department, AKH Linz, Austria

**Background:** Non-treated esophageal varices have a mortality of 30-50% in acute bleeding. Different endoscopic and pharmacologic methods for stopping the acute bleeding exist but there are 20% of the patients that need to be treated by placement of a balloon sonde.

The aim of this study was to assess the treatment method of implanting a self-expanding stent for stopping acute bleeding from esophageal varices.

**Methods:** In a multidisciplinary approach we implanted between January 2003 and August 2006 in 39 patients with acute bleeding from esophageal varices a self-expanding stent (SX-ELLA stent Danis). In all patients common methods to stop bleeding failed. With a new delivery system the stent was implanted and position was controlled by endoscopy and computer tomography.

**Results:** In all 39 patients the implantation of the esophageal stent was successful and acute bleeding could be stopped. There were no complications from stent implantation. No recidive bleeding during the stent implantation (median time 4 days, range 2-7) from esophageal or gastric varices was noticed.

In all patients the stent could be extracted by endoscopy with a foreign body forceps without any complications or recidive bleeding.

**Conclusion:** With the implantation of a self-expanding stent for stopping acute bleeding from esophageal varices a new therapeutic method exist. Our initial results with no method-related mortality and no complications show that this new method is safe and effective.

## S066

**GASTRIC BYPASS POUCH AND STOMA REDUCTION USING A TRANSORAL ENDOSCOPIC ANCHOR PLACEMENT SYSTEM: A FEASIBILITY STUDY**, Daniel M Herron MD,Desmond M Birkett MD,Marc Bessler MD, Lee L Swanstrom MD, Mount Sinai Medical Center, New York, NY; Lahey Clinic, Burlington, MA; Columbia University Medical Center, New York, NY; Legacy Health System, Portland, OR

**Background:** Weight regain after Roux-en-Y gastric bypass may be caused by pouch enlargement or dilatation of the gastrojejunostomy (stoma). In order to avoid the substantial morbidity of revisional bariatric surgery, investigators have recently demonstrated the feasibility of reducing stoma diameter using transoral endoscopic suturing techniques. Our aim was to demonstrate the feasibility of performing both pouch and stomal reduction using transoral endoscop
<figure><img src="image_22.png" /></figure>

cally placed tissue anchors in an ex-vivo and acute animate model.

**Methods:** Part I: We created an ex-vivo model of a dilated gastric pouch and stoma using 4 explanted porcine stomachs. The stomach was divided to create an upper pouch of approx. 100 ml volume, which was reconnected to the lower portion of the stomach (gastric remnant) via an anastomosis of 18 to 20 mm diameter. Endoscopically placed anchors were then used to create plications of the stoma and reduce its diameter. In 2 stomachs, anchor plications were also used to decrease pouch volume. Pouch volumes and stoma diameters were measured pre- and post-procedure. Part II: A similar experimental model was created in vivo using 2 pigs. Anchors were placed in the stoma and pouch. The animals were immediately sacrificed and similar measurements were obtained.

**Results:** In the ex vivo model, stoma diameter was successfully reduced in all 4 stomachs by a mean of 8mm (41%). This represented a mean decrease in cross sectional area of 65%. Pouch volume was reduced by a mean of 28 ml (30%) in 2 stomachs. Stomal plications were successfully placed in 1 of the live animals, with a stoma diameter reduction of 8 mm (35%). Feasibility of pouch reduction using plicating anchors was confirmed.

**Conclusions:** This is the first study to demonstrate the feasibility of using endoscopically placed tissue anchors to reduce both stoma diameter and pouch volume. This technique may ultimately be clinically useful in treating weight regain after gastric bypass surgery.

## S067

### CHRONIC IN-VIVO EXPERIENCE WITH AN ENDOSCOPICALLY DELIVERED AND RETRIEVED DUODENAL-JEJUNAL

**SLEEVE IN A PORCINE MODEL**, Michael E Tarnoff MD, Keith S Gersin MD, Anthony Lembo MD, Tufts-New England Medical Center, Boston, MA; Beth Isreal Deaconess Medical Center, Boston, MA; Carolinas Medical Center, Charlotte, NC

**Background:** Despite the widespread safety and efficacy of obesity surgery, life threatening complications can occur. We report the initial feasibility study of a totally endoscopically delivered and retrieved duodenal-jejunal bypass sleeve in a porcine model.

**Methods:** The implant consists of a 60 cm fluoropolymer sleeve that is endoscopically deployed via a coaxial catheter system into the jejunum and fixed in the proximal duodenum with a Nitinol anchor. The system creates a proximal biliopancreatic diversion. Six female Yorkshire pigs were endoscopically implanted and survived. Four animals (group 1) were slated to survive 90 days, 2 animals (group 2) for 120 days and 3 animals (group 3) underwent sham endoscopy and were survived 120 days. Animals were fed standard dry pig chow 0.5 kg three times daily. Data points included daily general health, weekly weight, serum blood tests (complete blood count, amylase, lipase, liver function tests), and monthly evaluation of anchor/sleeve position/patency by x-ray, fluoroscopy and endoscopy. Following the in-vivo period, the devices were endoscopically removed and the animals were sacrificed. Duodenal/jejunal tissue samples were assessed histologically.

**Results:** All 6 test animals were implanted and explanted without adverse events and had normal serum values. Three of 4 group 1 animals survived 90 days. Of these, 1 animal had no device-related issues. One animal was found to have a pivoted anchor that was repositioned at day 63. The animal went on to 90 days without incident. The third animal was explanted at 90 days but the anchor was found partially rotated. The animal had been asymptomatic. The fourth animal was incidentally implanted with a crossover of the anchor struts. This was endoscopically repaired on day 14 but explanted on day 20 when the animal had persistent vomiting. Both group 2 animals survived 120 days. One animal had a partially rotated anchor but was asymptomatic. The average weight gain between test and sham groups was 0.23 kg/day and 0.42 kg/day, respectively (p=0.01). There were no ulcers or strictures and the tissue reactions at the anchor sites were acceptable.

**Conclusions:** A totally endoscopic and reversible bypass of

the duodenum and proximal jejunum has been achieved for 120 days. Initial experience suggests patency of the sleeve and acceptable tissue response. Reduced weight gain in the test animals suggests device efficacy. Further investigation is warranted.

## S068

### PRE-CLINICAL TRIAL OF A MODIFIED GASTROSCOPE THAT PERFORMS A TRUE ANTERIOR FUNDOPLICATION FOR THE ENDOLUMINAL TREATMENT OF GERD, W Kauer PhD, A

Roy-Shapira PhD, H J Stein PhD, D Watson PhD, M Sonnenschein, J Unger MD, M Voget MD, University Hospital Salzburg, Soroka University Medical Center Beer Sheva, Flinders University Adelaide, MediGus Ltd Omer, Charite Virchow Clinic Berlin, Econ Inc. Luebeck

**Background:** Laparoscopic fundoplication provides good reflux control but side effects due to the surgical procedure are known. Different endoluminal techniques have been introduced but all with disappointing results.

**Objective:** Evaluation of the feasibility and safety of a new device, that enables a totally endoluminal anterior fundoplication for the treatment of GERD.

**Material:** The device is a modified video gastroscope, which incorporates a surgical stapler (using standard 4.8 B shaped surgical staples) and an ultrasonic sight. The cartridge is mounted on the shaft and the anvil is at the tip. This enables accurate stapling of the fundus to the esophagus, using the ultrasonic sight to guide distance and alignment of the anvil and the cartridge.

**Method:** Sixteen female swine of mixed breed were used in the study, 12 underwent the endoscopic procedure, and 4 were used a controls to monitor weight gain. The 12 study animals were sacrificed at 2, 4, and 8 weeks (4 pigs each time) and visually inspected for complications, healing and fundoplication. The study was sponsored by MediGus Ltd. and monitored for compliance with GLP regulations by an external company (Econ Inc.), which is GLP certified by the German Federal Government. It was conducted at the animal testing facility of the Charite Virchow Clinic in Berlin.

**Results:** The procedure went smoothly in all pigs, median procedure time was 12 minutes (range 9 - 35 minutes). At sacrifice the stapled area had healed well, all animals had a satisfactory 180° anterolateral fundoplication, and there were no procedure related complications.

**Conclusions:** Creating a satisfactory anterior fundoplication with the new device is feasible, easy, and safe. Proof of efficacy must await clinical trials, which are underway.

## S069

### ESOPHYX? ENDOLUMINAL FUNDOPLICATION (ELF) FOR THE TREATMENT OF GERD, Nicole Bouvy PhD, Bart

Witteman MD, Ronald van Dam MD, Wim Hameeteman PhD, Ger Koek PhD, University Hospital Maastricht, department of surgery

**Background:** Previous work has suggested that the anatomy of the gastroesophageal junction can help define propensity to reflux. In this study the first patients, treated with this Esophyx (ELF) device, are evaluated

**Method:** Pre-operatively patients were selected having a small hernia diafragmatica (<4cm) and having an abnormal 24 hours pH metry. In a retroflexed endoscopic view pre-operative Hill classifications were measured. Directly post-operatively the created valve was measured and photographs were taken of the result. Two weeks after this procedure patients were allowed to stop their PPI's.

**Results:** ELF was performed safely in all 14 patients. Intraoperatively solid full-thickness fundoplication were achieved in all patients, which resulted in robust valves. At baseline valve grading according to Hill, et al. (grades I-IV), a mean grade 2.5 valve was found in retroflexed endoscopic. Immediately after the ELF procedure, all newly-created valves were graded as a grade I. After 2 weeks, QOL scores of all patients were improved and 14 out of 15 patients were able to stop PPI.

**Conclusions:** The Esophyx procedure appears to be safe and efficacious in creating robust gastroesophageal valves. Most patients were able to stop PPI's after two weeks.
<figure><img src="image_23.png" /></figure>

## S070

### GASTROPARESIS ASSOCIATED WITH GERD AND CORRESPONDING REFLUX SYMPTOMS MAY BE CORRECTED BY RADIOFREQUENCY ABLATION (RF) OF THE CARDIA AND ESOPHAGOGASTRIC JUNCTION.
Mark D Noar MD, The Heartburn and Reflux Center - Endoscopic Microsurgery Associates

Gastroesophageal reflux (GERD) is a common problem among the adult population. Approximately 20% of patients will have unmanageable symptoms despite treatment with BID PPI's. Clinical evidence suggests delayed gastric emptying may be a causative factor for severe reflux, occurring in 25% of patients with GERD, and has been known to improve following Nissen fundoplication. RF treatment for GERD may also potentially correct GERD-associated gastroparesis. AIM: To determine if RF treatment for GERD will result in improvement of gastroparesis and symptoms in patients with abnormal Gastric Emptying Scans (GES) and refractory GERD.

**METHODS:** In July 2000-July 2004, 227 patients undergoing RF (Stretta) correction for GERD were screened for gastroparesis. Those with gastroparesis, on standardized GES, and GERD uncontrolled by BID PPI's had RF ablation of the cardia and EGJ by Stretta procedure. Prior to and 6 months post-treatment, all had EGD, manometry, and solid-phase GES, electrogastrography, and standardized heartburn, dyspepsia and satisfaction surveys. Patients with pyloric obstruction or taking motility agents were excluded. The nuclear radiologist was blinded to study design.

**RESULTS:** 31 patients had abnormal baseline GES. At 6 months, emptying scores improved significantly with the percentage of solid food emptied at 90 minutes improving from 41% to 66% post-Stretta (p<0.0001). GES at 120 minutes improved from 55% to 84%. 23 patients (74%) had normalization of gastric emptying, 4 improved but remained abnormal, and 4 showed no improvement.

<table><thead><tr><th></th><th>30 Pre</th><th>30 Post</th><th>60 Pre</th><th>60 Post</th><th>90 Pre</th><th>90 Post</th><th>120 Pre</th><th>120 Post</th></tr></thead><tbody><tr><td>Value</td><td>16.2</td><td>25.6</td><td>39.1</td><td>48.8</td><td>41.1</td><td>65.7</td><td>55.3</td><td>64.1</td></tr><tr><td>Std Dev</td><td>18.2</td><td>18.2</td><td>48.8</td><td>28.5</td><td>41.1</td><td>29.5</td><td>64.1</td><td>22.4</td></tr><tr><td>P value</td><td>&lt;0.01</td><td>&lt;0.01</td><td>&lt;0.03</td><td>&lt;0.03</td><td></td><td>&lt;0.0001</td><td></td><td>&lt;0.0001</td></tr></tbody></table>

All patients have one-year follow-up with significant improvements in GERD HRQL.

(Velanovich) scores and patient satisfaction.

<table><thead><tr><th>GERD HRQL</th><th>Baseline Off<br>Medds</th><th>Baseline On<br>Medds</th><th>6 Months</th><th>One year</th></tr></thead><tbody><tr><td>GES Normalized</td><td>25.91</td><td>18.74</td><td>8.04</td><td>5.33<br>p=0.0001</td></tr><tr><td>GES Abnormal</td><td>36.75</td><td>25.13</td><td>14.00</td><td>11.75<br>p=0.024</td></tr></tbody></table>

**CONCLUSIONS:** 1) RF treatment is demonstrated to correct gastroparesis, 2) GERD symptoms improved significantly, 3) RF correction, similar to Nissen, can result in reversal of gastroparesis, 4) Mechanism of action may be reduced TLESRs, decreased esophageal venting, increase in EGJ barrier, or gastric pacemaker alteration.

## S071

### EXPANDABLE METAL STENT PLACEMENT FOR BENIGN COLORECTAL OBSTRUCTION: OUTCOMES IN 23 CASES,
Aaron J Small BS,Tonia M Young-Fadok MD,Todd H Baron MD, Mayo Clinic College of Medicine

**INTRODUCTION:** Self-expanding metal stents (SEMS) are an established treatment for palliation of malignant colorectal strictures and as a bridge to surgery for acute malignant colonic obstruction. Patients with benign colonic strictures may benefit from stent placement, but little data exists for this indication.

**METHODS:** All cases of colonic stent placement identified from a GI database from 4/99-8/06 were reviewed. During the study period, 23 patients with benign obstructive disease underwent endoscopic SEMS placement. Etiology of the stricture: Crohn's disease (n = 1), postsurgical anastomotic (n = 3), radiation-induced (n = 3), and diverticular/inflammatory (n = 16). All strictures were located in the left colon. Five patients had an associated colonic fistula. Uncovered Enteral Wallstents or Precision Ultraflex stents (Boston Scientific) were endoscopically placed in all but one patient.

**RESULTS:** Stent placement was technically successful in all

23 patients; obstruction was relieved in 22 (95%). Major complications occurred in 38% of patients: migration (n = 2), reobstruction (n = 4), and perforation (n = 2). Of these 8 patients with major complications, 7 were delayed (>=7 days after placement). Of the 19 patients who underwent planned surgical resection, 16 were successfully decompressed and converted from an emergent operation to an elective one with a median time to surgical resection of 12 days (range, 2 days - 18 months). Of these, surgery was delayed >30 days after stent placement in 6.

**CONCLUSIONS:** SEMS can effectively decompress high-grade, benign colonic obstruction allowing elective surgery. SEMS can offer medium-term symptom relief for benign colorectal strictures but is associated with a high rate of delayed complications. Thus, if elective surgery is planned, data from this small study suggests it should be performed within 7 days of stent placement.

## S072

### MINIMALLY INVASIVE HEMORRHOIDECTOMY: THE HAL PROCEDURE,
Matthew R Albert MD,Paul Mancuso
MD,Sergio Larach MD, Department of Colorectal Surgery,
Florida Hospital, Orlando,FL

**ABSTRACT:** Hemorrhoidal Arterial Ligation (HAL) has been performed as an alternative to surgical hemorrhoidectomy since 1995. Despite very positive outcomes in the surgical literature worldwide, a 90-95% success rate, and minimal postoperative pain, the procedure has not been widely adopted in the United States. The authors describe the first case series in the american literature using the most updated HAL device for grade II-III hemorrhoids.

**METHODS:** The HTS? Doppler-Guided Hemorrhoid Treatment System uses a proctoscope combined with a single use Doppler probe to rapidly identify and suture ligate the terminal branches of the hemorrhoidal arteries several centimeters above the dentate line. In addition the newly devised longitudinal operating windows allow suture hemorrhoidopexy to be performed correcting prolapsing internal hemorrhoids. 50 consecutive patients (mean age 52 years; range 28-69 years) with grade II and III hemorrhoids were treated with hemorrhoidal arterial ligation and hemorrhoidopexy.

**RESULTS:** Postoperative pain and return to work was determined by postoperative questionnaires and visual analog scale. Patients were examined at 2 and 6 weeks and 6 months postoperatively. Hemorrhoidal bleeding resolved in 93% of patients and prolapse in 98% of patients. Complications were recorded in one patient who developed bleeding 1 week postoperatively requiring an ER visit but no further therapy. Pain was greater than expected in most patients with a mean score of 5.6, however return to work or daily activities was 4.3 days.

**CONCLUSION:** Hemorrhoidal arterial ligation is a safe, effective, and less painful alternative to surgical and stapled hemorrhoidectomy for symptomatic grade II and III hemorrhoids. Prolapsing hemorrhoids are effectively treated as well with a combination of hemorrhoidopexy and suture ligation of the offending vessel likely enabling its use in grade IV hemorrhoids. An extremely low risk of complications also makes this procedure an attractive alternative to other procedures.

## S073

### SHOULD SURGICAL NOVICES TRADE THEIR RETRACTORS FOR JOYSTICKS? VIDEOGAME EXPERIENCE DECREASES THE TIME NEEDED TO ACQUIRE SURGICAL SKILLS,
Matthew D Shane MD,Barbara J Pettitt MD,Craig B Morgenthal MD,Leena Khaitan MD,Edward Lin DO,C. Daniel Smith MD, Emory Simulation, Training and Robotics (E*STAR), Emory University

**Introduction:** Video game experience (VGE) has been identified as a possible predictive factor for surgical skill. We hypothesized that surgical novices with previous VGE would acquire new surgical skills faster than those without.

**Method:** 4th year medical students (M4) and 1st year surgical residents (PG-1) completed a survey asking about stan-