# SAGES POSTER ABSTRACTS

<figure><img src="image_185.png" /></figure>

tions (5 treated by Choledocho-jejunostomy ( CJ ) and 1 by primary T-tube repair (TTR) on conversion), 11 Lateral BDI (2 treated by Lap CJ,1 by open CJ ,5 Lap TTR, 1 open TTR while 2 with suture repair of which 1 was converted ) and 15 cases of Sectoral duct / Duct of Luschka injuries. Total 23 BDIs were managed Laparoscopically while 9 were converted to open surgery. 20 cases of BC were detected post operatively of which 6 had Bilioma ( treated with USG guided aspiration ), 4 had Biliary Peritonitis requiring re laparoscopy followed by ERCP and biliary stenting while 10 patients had persistent Biliary leak requiring ERCP stenting.There was no mortality related to BC in the series. 3 injuries occurred in the first 100 LC's , 17 in the first 500 and 24 in the first 1000.

The oral presentation high lights the video clippings of mechanism of different BC involving all spectrum, the ways and means of detection and subsequent management of the injuries.

## Minimally Invasive Other – P500

**LAPAROSCOPIC VERSUS OPEN APPENDECTOMY IN PREGNANCY:** INFLUENCE ON MATERNAL AND FETAL OUTCOMES, Maxim Petrov MD,Matthew J Sheldon BA,Ashley H Vernon MD,Stanley W Ashley MD,David C Brooks MD, Ali Tavakkolizadeh MD, Brigham and Women's Hospital

**Background:** There has been significant debate regarding the safety of laparoscopy in pregnant women. The increased intra-abdominal pressure is thought to result in impaired fetal circulation, fetal acidosis and possibly adverse fetal outcomes. Appendectomy is the commonest non-obstetric surgical procedure in pregnancy. We investigated the outcome of laparoscopic appendectomy (LA) in pregnancy and compared it to open appendectomy (OA).

**Methods:** A retrospective chart review of all pregnant women who underwent an appendectomy between January 1997 and January 2006, at Brigham and Women's hospital. Primary study end points were maternal and fetal outcomes. Institutional approval was received for the research project. Data were compared using Fischer's exact test.

**Results:** We identified 86 pregnant women who fulfilled our criteria. There were no differences between the 2 groups in terms of maternal age, gestational age, and trimester at operation (Table 1).

<table><thead><tr><th></th><th>OA</th><th>LA</th></tr></thead><tbody><tr><td>Total no of Pts</td><td>72</td><td>14</td></tr><tr><td>First Trimester</td><td>30</td><td>6</td></tr><tr><td>Second Trimeste</td><td>25</td><td>3</td></tr><tr><td>Third trimester</td><td>17</td><td>5</td></tr></tbody></table>

LA was attempted in 14 cases, with one conversion to open surgery (conversion rate=7%). There were no maternal deaths. Overall, 6% of pregnancies were lost, with no significant difference between the two groups (5.5% for OA vs. 7% for LA, p>0.05). There was one fetal loss in the third trimester (29 weeks) in the open group. There was one neonatal death. This baby was delivered at 32 weeks, but died of sepsis and respiratory distress. The length of post-operative hospital stay was similar between the 2 groups (3.6 days vs. 3.6 days, p>0.05).

**Conclusions:** Our data demonstrates no difference between LA and OA in terms of our primary end points of maternal and fetal outcomes. Although LA seems to be a safe procedure in pregnancy, it does not offer a significant advantage in terms of length of hospital stay.

## Minimally Invasive Other – P501

**MODIFIED OPEN TECHNIQUE FOR MINIMALLY INVASIVE ENDOSCOPIC SURGERY,** Daniel B Wool MD,Jonathan A Myers MD,Keith W Millikan MD, Rush University Medical Center

Obtaining access to the peritoneal cavity during laparoscopic surgery can be achieved in a variety of ways. Options include the use of a Veress needle, optical trocar, and the open technique with a Hasson or balloon tip trocar. The open technique allows direct visualization of trocar insertion which potentially reduces vascular and visceral injuries. However, this technique has been criticized for not achieving

a tight seal with escape of pneumoperitoneum and because additional time is needed to secure abdominal closure at the end of the case. We describe an alternative open method which utilizes a pursestring suture to address these concerns.

A small skin incision is made and the fascia is exposed. A pursestring of absorbable suture is placed through the fascia and an incision is made in the center. A standard trocar sheath is inserted under direct vision into the peritoneal cavity. The pursestring is then tightened around the trocar with a Rommel catheter and pneumoperitoneum is established. Upon completion of the surgery, the sheath is removed and the pursestring suture is tied to close the fascia. No additional sutures are necessary to reapproximate the fascial defect.

This modified open technique has the advantage of keeping the fascial defect smaller than alternative open techniques while maintaining a tight seal for pneumoperitoneum. It can be used both for laparoscopic and thoracoscopic access using any size trocar. This method also allows rapid closure of the fascial defect at the end of the case.

## NOTES (Natural Orifice Transluminal Endoscopic Su – P502

**THE PHYSIOLOGIC EFFECTS OF NOTES IN A PORCINE MODEL:** COMPARISON WITH STANDARD LAPAROSCOPY, Juliane Bingener MD,John Winston MD,Vicky Haines MS,Joel Michalek PhD,Kent Van Sickle MD,Arup Saha MD,Peter Lopez MD,Wayne Schwesinger MD, UTHSCSA

**Background:** The NOTES technique has been established as feasible and is thought to be less invasive by eliminating abdominal incisions. It is unclear if the technique is truly less invasive than the current standard. We hypothesized that during pneumoperitoneum with manually regulated air pressure insufflation (NOTES) cardiopulmonary parameters would show greater hemodynamic instability compared to pressure regulated CO2 insufflation (laparoscopy).

**Methods:** 12 pigs were assigned to standard laparoscopy or NOTES with permuted block randomization. Each group underwent 90 minutes of diagnostic peritoneoscopy by the respective access technique. Cardiopulmonary parameters were recorded in 2.5 minute intervals using invasive monitors feeding into a data recorder. Treatments were contrasted on the mean outcome using a repeated measures linear model with an autoregressive order one autocovariance structure.

**Results:** All 12 experiments were successfully completed. Transient respiratory compromise resulted in 2 in the laparoscopy and 1 in the endoscopy group. The systolic blood pressure (Sbp) and diastolic blood pressure (Dbp) remained at baseline in the laparoscopic group compared to decreasing pressures in the NOTES group. The bladder pressure and the endtidal CO2 (ETCO2) were significantly higher in the standard laparoscopy group.

<table><thead><tr><th>Variable</th><th>Avg mean diff</th><th>SE</th><th>p-value</th></tr></thead><tbody><tr><td>Sbp (mmHg)</td><td>14</td><td>2.8</td><td>&lt;0.001</td></tr><tr><td>Dbp</td><td>19</td><td>1.4</td><td>&lt;0.001</td></tr><tr><td>Bladder press</td><td>7</td><td>0.8</td><td>&lt;0.001</td></tr><tr><td>ETCO2</td><td>10</td><td>3.1</td><td>0.002</td></tr></tbody></table>

**Conclusion:** Significant cardiopulmonary differences were encountered between the Notes and laparoscopic group. However no clear evidence of detrimental changes was encountered so far.

## NOTES (Natural Orifice Transluminal Endoscopic Su – P503

**PERCUTANEOUS ENDOSCOPIC ASSISTED SURGERY:** A FEASIBILITY STUDY OF NOVEL APPROACHES TO GERD AND WEIGHT LOSS, Royd Fukumoto MD,Julio Teixeira MD, St Luke's Roosevelt Hospital Center, Columbia University

**Objective:** This review examines the feasibility of a novel approach of endoluminal surgery for weight loss and the treatment of GERD. Both procedures were designed as minimally invasive methods of treating GERD and morbid obesity. Predicted populations eligible for these approaches are
<figure><img src="image_186.png" /></figure>

# SAGES POSTER ABSTRACTS

patients who are medically unstable for traditional laparoscopic or open anti-reflux and weight loss procedures.

**Methods:** Each of three dogs underwent a successful anti-reflux procedure and modified vertical banded gastroplasty. Access to the gastric cavity was provided by endoscopic visualization and percutaneous instrument access via one trans-abdominal port. The anti-reflux procedure consisted of internal plication of the gastro-esophageal junction using modified Belsley Mark IV type sutures. The weight loss procedure consisted of the creation of a gastric mucosal tunnel.

**Results:** Both procedures were successfully completed in each of three dogs.

**Conclusions:** Both anti-reflux and weight loss procedures were feasible in an animal model. Percutaneous endoscopic assisted access to the gastric cavity was easily performed, and all operations were completed as planned.

## NOTES (Natural Orifice Transluminal Endoscopic Su - P504

**MAGNETOCOLONOSCOPY, ASHOK JAGANATHAN, RAKHSITH HOSPITAL, MAGNETOCOLONOSCOPY**

It is used to take photograph, video of the colon and also to ablate polyps using laser

**STRUCTURAL COMPONENTS** Internal electromagnets inside the cylinder, camera, Light emitting diodes, Laser Wire supply to magnetocolonoscopy in its posterior end to feed camera, laser, diodes, External electromagnets mounted on robotic arm out side human body, Joystick for physician to direct movements, Computer system to control current flow and movement, Monitor to visualize camera output

**DESCRIPTION** Fed up with the large tube like colonoscopy, pain and discomfort. Now there is a small cylindrical structure with blunted anterior and posterior ends. The anterior end consist of a camera, laser and light emitting diodes. The cylinder consist of electromagnetic coils in its anterior, posterior and its sides. The current passing through these coils are individually controlled by a sophisticated computer software.

The colon is washed with enema and a long catheter with an inflatable balloon in its tip is passed through the anus till it reaches ileocaecal valve region, inflate it so that it seals the ileocaecal region. Then fill the lumen of the colon with saline to dilate it. Pass the magnetocolonoscopy in to the colon through the anus and seal the anal opening with water tight anal cap

Now the internal electromagnets are activated by passing electric current through it. Electromagnets that are fixed and moved on a robotic arm are placed on the external surface of the body when these external magnets are activated and moved on a robotic arm both its polarity and its movement will guide and direct the magnetocolonoscopy inside the colon

Magnetocolonoscopy can be moved and made to take photograph, video of the colon also the in built laser can be used to destroy any polyp or other growths in the colon ADVANTAGE: 1-Small and no discomfort unlike tube colonoscopy 2-guided and controlled unlike capsule endoscopy 3-inbuilt camera and light source 4-inbuilt laser for polypectomy

## NOTES (Natural Orifice Transluminal Endoscopic Su - P505

**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.

## NOTES (Natural Orifice Transluminal Endoscopic Su - P506

**A SURVEY OF ATTITUDES TOWARDS "NOTES" PROCEDURES AMONG POTENTIAL BARIATRIC PATIENTS, Eric K Osborne DO, Michael A Shear MS, Andrew B Lederman MD, E. Matthew Ritter MD, Robert D Fanelli MD, Surgical Specialists of Western New England, P.C., and Berkshire Medical Center**

**Introduction:** A survey was used to investigate the attitudes of patients considering bariatric surgery towards Natural Orifice Transluminal Endoscopic Surgery (NOTES).

**Methods:** A 9 section, 72 question survey was randomly distributed to attendees at an informational seminar about bariatric surgery; 43 surveys were completed. Responses were in the form of a 5-point Likert scale or yes/no as appropriate. Statistical significance was defined as p < 0.05 by 2-tailed t-test.

**Results:** Subjects reported familiarity with laparoscopic and open surgery, but had significantly less knowledge of NOTES. When subjects were asked to rank by order of preference methods for generic organ removal procedures the clearly preferred method was laparoscopy; open surgery was significantly less preferred, and NOTES was seen as the least preferable technique. When respondents were asked their opinion of the acceptability of different access orifices and techniques, laparoscopic surgery was significantly more accepted than any other technique. Open surgery was significantly more accepted than any NOTES orifices except for oral NOTES; NOTES by the oral route trended towards being accepted better than all other NOTES routes, but only reached significance compared to the nasal route. There was no significant difference between acceptability of other NOTES routes. Respondents were then asked what routes they would find acceptable for various operations on themselves. The acceptance of NOTES procedures in this question depended strongly on the distance from the entry site to the target organ; for example, foregut procedures (e.g. for weight loss or GERD) were well accepted by the oral route but not other routes. Similarly, NOTES GYN procedures were well accepted when trans-vaginal. Respondents expressed a tolerance for the same level of risk in NOTES as in current surgical methods, but no tolerance for increased risk despite expecting increased benefits.

**Conclusion:** NOTES will be accepted by bariatric patients, especially by the PO route. There is no tolerance for higher risk or worse outcomes regardless of the expected benefits of NOTES.
# NOTES (Natural Orifice Transluminal Endoscopic Su - P507

ENDOSCOPY-ASSISTED LAPAROSCOPIC TRANSLUMINAL RESECTION OF A GE JUNCTION TUMOR: A CASE REPORT, MORRIS E FRANKLIN JR MD, GUILLERMO PORTILLO MD, MATTHEW E SHEPHERD MD, JORGE M TREVINO MD, TEXAS ENDOSURGERY INSTITUTE

**BACKGROUND:** Endoscopic management of intraluminal pathology of the gastrointestinal tract is increasing in popularity. Despite this trend, some lesions are not amenable to endoscopic therapy. Endoscopic-assisted laparoscopic transluminal resection is a novel alternative to conventional surgery for intraluminal pathology that is not amenable to endoscopic management alone. We describe our technique for endoscopy-assisted laparoscopic transluminal resection of a neoplasm located at the gastroesophageal junction.

**METHODS:** The patient is positioned in the lithotomy position. Pneumoperitoneum is established and three 5mm trocars are placed. The stomach is mobilized free from the transverse colon, the lesser sac is opened, and the greater curvature of the stomach is exposed. A gastroscope is introduced and the mass at the GE junction is visualized. The 5mm trocar is placed through the stomach wall and the laparoscopic camera is inserted into the insufflated gastric lumen. Two 2mm instruments are placed through the remaining two trocars into the stomach for dissection. After the mucosa is incised, the specimen is enucleated. A gastrotomy is made for specimen removal and then sealed with an endoluminal stapler.

**RESULTS:** The patient tolerated the procedure well. Pathology of the specimen demonstrated a leiomyoma with negative surgical margins. A swallow study confirmed normal gastric emptying without evidence of leakage. The patient was discharged on post-operative day number four and has had an uncomplicated post-operative course.

**CONCLUSION:** Endoscopy-assisted laparoscopic transluminal resection is a safe and effective technique that can be utilized for select gastrointestinal tract tumors that would otherwise require more extensive surgical resections.

# NOTES (Natural Orifice Transluminal Endoscopic Su - P508

EARLY EXPERIENCE WITH VISCERAL CLOSURE IN NOTES PROCEDURES IN A PORCINE MODEL, John R Romanelli MD, David J Desilets MD, Vihar C Surti BS, David B Earle MD, Baystate Medical Center, Tufts University School of Medicine, Springfield, MA

**INTRODUCTION:** NOTES is an exciting new frontier in minimal access surgery. Early reports have focused on animal models. We have conducted three NOTES labs in live porcine models with a focus on visceral closure. While most papers achieve visceral closure with endoclips, reliability of this method remains open to debate.

**METHODS:** Three female Yorkshire pigs were utilized for the study. After induction of general anesthesia, pneumoperitoneum was achieved via a Veress needle. A laparoscope was placed for an external view. After gastric intubation, an overtube was placed over the endoscope into the stomach. T-fasteners with Prolene suture were placed through the gastric wall under direct vision. Needle-knife cautery was used to perform a gastrotomy. After advancing the endoscope into the peritoneum, visceral closure using the T-fasteners was attempted.

**RESULTS:** In the first lab, T-fasteners were deployed in a square orientation. Laparoscopic visualization confirmed successful placement. A gastrotomy was made, and the endoscope was advanced into the peritoneum. Insufflation was successfully maintained. An appendectomy was simulated with an endoloop and snare on small bowel, and the specimen was extracted through the overtube via the endo-

scope. Gastric closure was then attempted with extracorporeal knot tying of the sutures; this was unsuccessful as tight closure was not achieved. T-fastener placement and gastrotomy were duplicated in the second lab. Via colonoscopy, four T-fasteners were placed in the rectal wall above the peritoneal reflection. A colotomy was made, and peritoneal access was gained with the colonoscope. The colonoscope was then withdrawn, but colonic closure using extracorporeal knot tying was unsuccessful due to the awkward angle to reach the anterior colonic wall. Gastric closure using a proprietary crimping device over the four sutures was successful. Inspection with endoscopic insufflation confirmed closure without leak. In the third lab, T-fasteners were again placed. A gastrotomy was made with balloon dilatation over a guide wire. T-fastener closure with the crimping device was unsuccessful because the gastrotomy was created obliquely.

NOTES procedures are still in their infancy, especially in humans. Further studies are needed to discover appropriate visceral closure. Rectal access may be best achieved with a side-viewing endoscope or transabdominally. Technical development may aid future growth in this area.

# NOTES (Natural Orifice Transluminal Endoscopic Su - P509

TRANSGASTRIC VENTRAL HERNIA MESH REPAIR IN A PORCINE MODEL USING A NEW ENDOSURGICAL OPERATING SYSTEM, Marvin Ryou MD, Derek Fong MD, Christopher C Thompson MD, Department of Gastroenterology, Brigham & Women's Hospital; Harvard Medical School, Boston, MA, USA

**Background & Aims:** Laparoscopic ventral hernia repair has been shown to be superior to the open approach in terms of fewer complications, shorter hospital stays, and possibly a lower rate of recurrence. Natural Orifice Transluminal Endoscopic Surgery (NOTES) represents a potentially less invasive alternative to conventional laparoscopy. We report the first case of a transgastric ventral hernia mesh repair in a porcine model with the aid of the multi-lumen EndoSurgical Operating System (EOS) featuring ShapeLock technology from USGI Medical.

**Methods:** A single Yorkshire pig weighing 25 kg was used in this study. The ShapeLock TransPort? was backloaded with a 2x6 cm rectangular segment of ePTFE mesh (Bard) into one of the instrument ports and advanced into the gastric lumen of the anesthetized animal via an esophagotomy (as the TransPort length is designed for adult human anatomy). The device has three instrument ports and allows off-axis visualization and instrument introduction. A gastrotomy was created and the TransPort was introduced cleanly into the peritoneal cavity. Following a brief abdominal exploration, the mesh was affixed to the mid-anterior abdominal wall. This was accomplished using a specialized grasper and the g-Prox?, an endoscopic tissue-anchoring device. Tissue-anchors were deployed in random locations across the mesh piece. Afterwards, the animal was sacrificed and the relevant segment of abdominal wall was resected for gross inspection.

**Results:** The mesh was successfully affixed to the abdominal wall using novel tissue anchors. The EOS provided a stable endoscopic platform and allowed for easy manipulation of endoscopic devices. The novel tip provided the convenience of off-axis introduction of instruments into the field of operation. Upon visual inspection following necropsy, approximately 7 of tissue anchors deployed traversed the fascial plane.

**Conclusions:** Transgastric ventral hernia mesh repair is technically feasible. With modification of the g-Prox jaws for this application, consistent trans-fascial anchor deployment is likely. Further studies in a survival porcine model of ventral hernias are forthcoming.
<figure><img src="image_187.png" /></figure>

SAGES POSTER ABSTRACTS

# NOTES (Natural Orifice Transluminal Endoscopic Su - P510

NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (NOTES) AND LAPAROSCOPY: A DOCUMENTATION ON ENDOSCOPE ORIENTATION, MANIPULATION AND INSTRUMENTATION IN A PORCINE MODEL: A LABORATORY WORK BY AN INDEPENDENT ENDOSCOPIC AND LAPAROSCOPY CENTER, Ray Sarmiento MD,V.J. Villaflor MD,Gozar Duque MD,Vivencio Villaflor MD,Narciso S Navarro MD, Dagupan Endoscopic and Laparoscopic Surgery Center Inc., Dagupan Doctors Villaflor Memorial Hospital, Dagupan City, Philippines

NOTESurgery theoretically provides lesser surgical trauma by avoiding the abdominal wall. The gastroscope endoscopically punctures the stomach and gains access into the peritoneal cavity. Human appendectomies and procedures in animal models were reported.

The objectives are to gain experience on how the flexible gastroscope (Olympus GIF-XQ30) and its accessories behaves inside the peritoneal cavity of a porcine model and to provide an endoscopic and laparoscopic documentation of this.

Proper animal handling was observed. A puncture was made through the stomach's anterior wall using a needle-knife (Boston Scientific) until a guidewire goes blindly into the peritoneal cavity. The scope itself dilates the perforation until inside the cavity. The bowels were the initial organ visualized. Pneumoperitoneum was inadequate after endoscope insufflation making orientation difficult. The inner side of the abdominal wall was visualized after much manipulation with orientation guided externally by transillumination from the scope. The laparoscopy team then created pneumoperitoneum and assisted in retraction - a form of hybrid surgery. A tubular structure was retracted using lap instruments and its peritoneal attachments cut by the needle-knife. Endoscopic needle-knife adhesiolysis and hemostasis was done with precision. Grasping with multibite biopsy forceps (Boston Scientific) was inadequate to hold the whole structure. One Hemoclip (Olympus) was used to close the perforation. It was noted to be on one side of the perforation after sacrifice of the animal. The procedure was technically demanding. More experience in the animal model is needed. Support from the industry in terms of proper instrumentation is also needed

# NOTES (Natural Orifice Transluminal Endoscopic Su - P511

TRANSGASTRIC, TRANSCOLONIC, AND TRANSVAGINAL CHOLECYSTECTOMY USING MAGNETICALLY ANCHORED INSTRUMENTS, Daniel J Scott MD,Shou Jiang Tang MD,Raul Fernandez PhD,Richard Bergs MS,Jeffrey A Cadeddu MD, University of Texas Southwestern Medical Center, Dallas, TX. Automation and Robotics Research Institute, University of Texas, Arlington, TX.

**Introduction:** An ideal approach has not been developed for Natural Orifice Transluminal Endoscopic Surgery (NOTES). The purpose of this study was to compare various NOTES approaches for cholecystectomy using Magnetic Anchoring and Guidance System (MAGS) instruments.

**Methods:** Non-survival procedures were conducted in pigs (n=3) using a transgastric (TG, pig 1), transcolonic (TC, pig 2), or transvaginal (TV, pig 3) approach. An overtube (18mm inner diameter) was placed intralumenally and inserted into the peritoneal cavity through a 20mm opening in the stomach (prepyloric), colon (rectosigmoid junction), or vagina (posterior fornix) using a flexible gastroscope and a needle knife (all), sphincterotome (TG), balloon dilator (TC), or direct dilation (TV). MAGS instruments were deployed through the overtube and held in place on the peritoneal surface using magnetic coupling via an external handheld magnet; instruments, including a camera, tissue retractor (clip-fixated magnet), and cautery dissector, were then maneuvered using magnetic guidance. Two 5mm ports were placed transabdominally to maintain a CO2 pneumoperitoneum and for laparoscopic assistance as needed.

**Results:** Overtube insertion, instrument deployment, and magnetic anchoring and guidance were successful for all procedures. The MAGS camera was limited by fogging and a 5mm laparoscope was used in all cases. The MAGS retractor was successfully secured to the gallbladder with EGD clips but required additional laparoscopic suture fixation in all cases; the retractor uniformly provided excellent fundus retraction but a laparoscopic grasper was required for infundibulum retraction. In all cases, the MAGS cauterizer was used for 100% of the dissection of the gallbladder from the liver bed and facilitated complete gallbladder removal with extraction through the overtube using a Roth net or snare. Inadvertent magnetic coupling between instruments occurred in the first 2 cases (requiring a 3rd laparoscopic port in the TC procedure) but not in the final case. Access to the gallbladder using the flexible endoscope, including clipping the cystic duct and artery, was best for the transpelvic (TC, TV) approaches.

**Conclusions:** MAGS instruments may be successfully used for cholecystectomy via TG, TC, or TV routes, with transpelvic approaches best suited for access to the gallbladder. MAGS instruments facilitate tissue retraction and dissection, significantly enhance NOTES, and should be further developed.

# NOTES (Natural Orifice Transluminal Endoscopic Su - P512

INVESTIGATION OF TECHNICAL PROBLEMS FOR THE DEVELOPMENT OF NOTES ASSISTING SYSTEM, Kazuhiko Shinohara MD, School of Bionics, Tokyo University of Technology

Technical problems for the development of Natural Orifice Transluminal Endoscopic Surgery (NOTES) assisting system were surveyed by the method of Failure Mode and Effect Analysis (FMEA). The process of NOTES was simplified and classified into 6 steps, i.e. insertion of the endoscope, creation of the gastrotomy and access to the intraperitoneal space, intraperitoneal operation, retrieve of the specimen, closure of the gastrotomy, and extubation of the endoscope. Incidents and troubles were estimated in each step and technical problems to be conquered as the NOTES assisting system were investigated. Estimated failures of the NOTES caused by the factors of assisting system were the laceration of pharynx and esophagus during the insertion of devices and retrieve of specimen and devices, missed creation of the adequate gastrotomy and successive organ injury, bleeding and contamination from the gastrotomy, laceration of the gastrotomy during the procedure, ineffective irrigation and suction via the endoscope, leakage and bleeding after the closure of gastrotomy and so on. Not only the necessity of development of main endoscope for NOTES, but also the necessity of development for safe and smooth method and devices for the intubation of main endoscope via esophagus and creation of the intraperitoneal access through the gastrom, sterile and hemostatic management system for the overtube and gastrotomy during the operation, effective suction and irrigation system and reliable devices for the closure of gastrotomy were revealed in this study.

# Pediatrics - P513

LAPAROSCOPY-MEDIATED ATTENUATION OF BETA-FIBRINOGEN EXPRESSION IS LOST WITH AGE Eric J Hanly MD, Antonio De Maio PhD, Christopher A Gitzelmann MD, Walter Pegoli MD, Mario Mendoza-Sagaon MD, Mark A Talamini MD, Departments of Surgery, The Johns Hopkins University and University of California San Diego

**INTRODUCTION:** Hepatic expression of acute phase genes (such as beta-fibrinogen in rodents) results in altered synthesis of stress proteins which serve to regulate the response to inflammation or injury and defend against further tissue damage during system stress. Compared to conventional open surgery, laparoscopy with CO2 has been shown to attenuate the host response to surgical stress. However, because age-related differences exist in the expression of hormone-, and other protein groups, we
SAGES POSTER ABSTRACTS

pooled that the immunomodulatory effects of CO2 pneumoperitoneum may vary with age.

**METHODS:** Eighteen 3-week-old and 18 adult Sprague-Dawley rats were randomized into 3 groups each (n=6): Anesthesia only (Anes), Conventional laparotomy (Lap), and insufflation with CO2 (CO2). Procedure duration was 90 min for all groups after which livers were harvested and hepatic expression of beta-fibrinogen was determined by Northern blot/ hybridization analysis.

**RESULTS:**

<table><thead><tr><th></th><th></th><th></th><th></th></tr></thead><tbody><tr><td>b-fibrinogenAnesthes (Anes)</td><td>Laparotomy (Lap)</td><td>CO2 Lapar (CO2)</td></tr><tr><td>Infants (Inf)</td><td>0.25 ± 0.05</td><td>0.29 ± 0.06</td><td>0.18 ± 0.02*</td></tr><tr><td>Adults (Adult)</td><td>0.20 ± 0.01</td><td>0.47 ± 0.05††</td><td>0.51 ± 0.06††&#</td></tr></tbody></table>

*p<0.05 v Inf Lap; †p<0.01 v Adult Anes; ‡p<0.05 v Inf Lap; llp<0.01 v Inf CO2. Among infant rats, CO2 laparoscopy resulted in significant attenuation of beta-fibrinogen expression compared to laparotomy. However, this effect was lost among adult animals in which beta-fibrinogen expression was increased 2.5 fold for both laparotomy and CO2 laparoscopy compared to anesthesia alone.

**CONCLUSIONS:** Laparoscopy-mediated down-regulation of the rodent hepatic acute phase gene beta-fibrinogen occurs among infant rats. beta-fibrinogen expression is upregulated significantly more by laparotomy in adult rats than in infant rats, and the attenuating effects of CO2 laparoscopy on the expression of this gene are lost in older animals. Age-related differences in the genetic expression of stress proteins in response to inflammation and injury may make the immunologically beneficial effects of laparoscopy of greater clinical significance in children.

Pediatrics - P514

LAPAROSCOPIC REPAIR OF A BOCHDALEK'S HERNIA IN AN INFANT, G. Brent Sorensen MD, Daniel G Kolder MD, Venkataraman Ramachandran MD, University of Missouri Health Care

Congenital diaphragmatic hernias are relatively rare anomalies, occurring in approximately 1 in 5000 live births. These hernias are felt to be secondary to failure of normal closure of the pleuroperitoneal canal in the developing embryo. This results in herniation of abdominal contents into the thoracic cavity, resulting in compression of the developing lung. The usual presentation is respiratory distress due to severe hypoxia within 24 hours of birth. Less commonly, after 24 hours of life, infants can develop feeding difficulties, chronic respiratory disease, pneumonia, or intestinal obstruction. We present a 5 month old female with respiratory distress and concerns of left tension pneumothorax on chest X-ray. Computerized tomography revealed a diaphragmatic hernia. She was taken urgently to the operating room for laparoscopic repair of her Bochdalek's hernia.

On review of the literature, laparoscopic repair of a diaphragmatic hernia is rare. There has been only one reported case utilizing the laparoscopic approach to Bochdalek's hernia in an infant. This attempt failed and required conversion to thoracoscopy to complete the repair. We describe a successful laparoscopic approach to this challenging hernia.

Pediatrics - P515

CALCULOUS CHOLECYSTITIS AFTER LIVER TRAUMA IN A CHILD: A CASE REPORT, Sung Ock Suh, Tae Jin Song, Min Young Cho, Wan Bae Kim, Young Chul Kim, Jin Kim, Korea University Hospital

Gallbladder disease is quite uncommon during childhood and adolescence. Cholelithiasis is not often given serious consideration in differential diagnosis of abdominal pain. We report the development of calculous cholecystitis after hepatic injury in a 4 year-old child. He got grade III hepatic injury in a traffic accident. After a period of conservative treatment, the patient complained of abdominal pain.

Follow-up computed tomography of abdomen showed multiple stones in gallbladder which had not been shown in the initial study. He was successfully treated with laparoscopic cholecystectomy. Cholelithiasis after trauma is an unusual manifestation. The causative etiologic condition varies as

described above. But the conditions can be occurred to a traumatized patient simultaneously. So if a traumatized patient complains of abdominal pain after a period of conservative treatment, surgeon should consider gallstone formation even if the pre-treatment study did not revealed cholelithiasis.

Pediatrics - P516

THORACOSCOPY FOR MALIGNANCY IN CHILDREN, Abhilash Nair, Shawn D St. Peter MD, KuoJen Tsao MD, Daniel J Ostlie, George W Holcomb III BA, Children's Mercy Hospital

**Background:** The safety and efficacy of the minimally invasive approach for evaluating thoracic masses in children is evolving. Our experience with thoracoscopy for lesions that may represent malignancy has expanded in recent years. Therefore, we audited our experience to determine efficacy and to define future application of minimally invasive surgery for malignant diseases.

**Methods:** A retrospective review of all patients undergoing a thoracoscopic procedure for possible malignancy at The Childrens Mercy Hospital between January 1, 2000, and May 1, 2006, was performed. Data points reviewed included location of lesion, type of operation, operative time, histology diagnosis, complications, and recovery.

**Results:** Fifty-eight children with malignancy underwent a thoracoscopic procedure during the study period. Mean age was 11.3 years with mean weight of 36.9 kg. Wedge or segmental resections were performed for lesions in the lung parenchyma in 43 patients. Excisional biopsy was performed in 13 patients with lesions in the mediastinum, two patients had lesions in both locations. Mean operative time was 62 28 minutes in the lung group and 112 40 minutes in the mediastinal group. Definitive tissue diagnosis was established in all cases. Pre-operative localization was utilized in 14 cases, with a wire in 11 cases, methylene-blue injection in 1 case, and both techniques were used in 2 cases. There were no post-operative complications. One patient in the mediastinal group had intraoperative spillage of a malignant schwannoma which represented the only intra-operative complication in this series. The majority of patients were discharged in 2 days or less following the procedure, the remainder staying in the hospital for cancer-related treatments.

**Conclusions:** In pediatric patients with suspected cancer, thoracoscopy is a highly accurate approach with minimal morbidity allowing for adequate assessment of resectability, staging, and for evaluation of recurrent or metastatic disease.

Robotics - P517

GASTRIC STIMULATOR PLACEMENT FOR GASTROPARESIS: OUR EXPERIENCE WITH THE DA VINCI ROBOT. Phillip Price MD, Brent Ziegler MD, J Andres Astudillo MD, Mount Carmel Health System, Department of Surgery, Columbus, OH

**Background:** Gastric Electrical Stimulation (GES) is one of the last alternatives for the management of severe gastro-paresis. Prior to reaching this point most of the resources for treatment have been utilized. GES has shown good results in the management of this problem. Placement can be done either with open or laparoscopic surgery with good results. Another option is laparoscopic placement with the DaVinci Robot due to the fact that the work area is small and the core of the operation is securing the leads intramurally to the gastric wall with intracorporeal sutures. This is an area in which the Robot excels.

**Methods and procedures:** From January 2004 to September 2006 22 gastric stimulators have been placed in our institution. 3 in an open procedure, 14 laparoscopically and 4 using de DaVinci Robot. All procedures where completed without complications.

To our knowledge, and doing an extensive review of literature and by information form the INTUITIVE and the MEDTRONIC representatives this are the first cases done robotically.

**Results:** Gastric stimulator placement with the DaVinci Robot is feasible, and the robot is well suited for this procedure. The hospital stay is similar to nonrobotic laparoscopic

<figure><img src="image_188.png" /></figure>
<figure><img src="image_189.png" /></figure>

# SAGES POSTER ABSTRACTS

placement. Advantages are the possibility to work in a reduced surface area with secure suture fixation of the leads due to ease of laparoscopic suturing provided by the robot.

## Robotics - P518

**ROBOTIC PARAESOPHAGEAL HERNIA REPAIR COMPARES FAVORABLY TO LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR**, Ward J Dunnican MD, T. Paul Singh MD, Gloria G Guptill BS, Michael G Doorly MD, Albany Medical College Little information regarding the use of robotic surgery for the treatment of paraesophageal hernias (PEH) currently exists. Studies have examined the use of robotic surgery for the treatment of GERD, excluding those patients with PEH. We studied the 30-day outcomes of Robotic PEH (RPEH) repair compared with Laparoscopic PEH (LPEH) repair to determine if Robotic PEH repair would be a feasible option for repair of PEH.

A retrospective review of all patients who underwent minimally invasive PEH repair between August 2004 and May 2006 by a single surgeon were studied. Demographic information, operative times, narcotic use, length of stay, and perioperative complications were analyzed for statistical significance using the Mann-Whitney U test.

Ten patients underwent LPEH and 7 patients had RPEH. There was no calculated statistical difference between both groups in regard to age, body mass index, co-morbidities, number of prior operations, ASA class, type of PEH (e.g. III, IV), estimated blood loss, length of stay and 30 day complications. Operative times were similar between the RPEH and LPEH (RPEH: mean 195 min, range 101-266 min; LPEH: mean 174 min, range 97 to 262 min; p-value=0.89). Patients with RPEH (1) were less likely to undergo repair with mesh when compared to the LPEH (9).

Patients undergoing Robotic PEH repair have similar short term outcomes compared to patients undergoing Laparoscopic PEH repair. Patients undergoing Robotic PEH repair may be less likely to require mesh reinforcement. Long-term follow-up is necessary to detect recurrence and other potential complications of PEH repair by either modality. Given the limitations of our study, we feel that Robotically performed anti-reflux operations complicated by the presence of a PEH have equivalent short term outcomes compared to Laparoscopic repair.

## Robotics - P519

**COMPARISON OF DEXTERITY BETWEEN BEGINNERS WITHOUT LAPAROSCOPIC EXPERIENCE AND LAPAROSCOPIC SURGEONS IN THEIR FIRST USE OF THE DA VINCI ROBOT**, Monika E Hagen MD, Isan Ihnan MD, Schindler M Philipp, Philippe Morel PhD, University Hospital Geneva

**BACKGROUND:** Due to improved ergonomics and dexterity, robotic surgery is supposed to be much easier than laparoscopy, especially for inexperienced individuals. We tested the null hypotheses that the performance of inexperienced individuals using the da Vinci® robot is not different than with conventional laparoscopic equipment and there are no differences between inexperienced and laparoscopic trained surgeons.

**AIM:** The aim of this study was first, to clarify how beginners perform specific tasks robotically and laparoscopically and second, to compare the performance of beginners with laparoscopic surgeons.

**METHODS AND DESIGN:** 34 individuals were tested for robotic and laparoscopic dexterity. Group 1 included 18 surgical inexperienced students and doctors (age 25 to 35). Group 2 included 16 experienced laparoscopic surgeons (age 30 to 60). Each individual performed an easy, a medium and a difficult tasks both robotically and laparoscopically 10 times. Time and errors were measured, an overall score allocated and evaluated statistically.

**RESULTS:** Group 1 performed all 3 of their allocated tasks significantly better using the da Vinci robot when compared to their performance using conventional laparoscopic equipment (p<0,05). Group 2 performed significantly better with the robot for the medium and the difficult task in comparison to laparoscopy.

(p<0,05). Differences were not significant for the easy task. No significant differences between group 1 and 2 were found when performing the easy task both with the robotic and laparoscopic equipment. There were no significant differences between the two groups performing the medium task with the robot, while group 2 was superior to group 1 in laparoscopy for the same task (p<0,05). For the difficult task, group 2 performed significantly better than group 1 with both robotic and laparoscopic equipment (p<0,05).

**CONCLUSION:** The data support the conclusion that the performance of inexperienced individuals using the da Vinci® robot is superior to their performance with conventional laparoscopic equipment. The difference in performance of inexperienced individuals and experienced laparoscopic surgeons is less evident while using the robotic system when compared to conventional laparoscopy, but experienced laparoscopists are superior in difficult tasks.

## Robotics - P520

**DEVELOPMENT OF A NEW ROBOTIC ASSISTANT SYSTEM FOR LAPAROSCOPIC SURGERY**, Kazuyuki Okada MD, Shuji Takiguchi MD, Yuichiro Doki MD, Makoto Yamasaki MD, Hiroshi Miyata MD, Yoshiyuki Fujiwara MD, Mitsugu Sekimoto MD, Morito Monden MD, Dept. Gastroenterological Surg., Grad. Sch. Med., Osaka Univ.

**[Purpose]** During the last five years, there has been an increasing development and experience with robotics in laparoscopic surgery. A robotic assistant system such as AESOP was developed as a voice-controlled camera-arm to provide precise positioning of the laparoscope and stable image without the support of the human camera assistant. However, operating this system was stressful for surgeons, because they had to voice-control the motion of the laparoscope. Thus, we?ll report about the prototype of robotic assistant system, which has an intraoperative 3D instrument tracking system.

**[Method]** By using 3D instrument tracking system, the laparoscope automatically can trace the tip of the right surgical instrument with centering the workspace in the laparoscopic image. Moreover, if surgeon preoperatively decides several workspaces and appropriate scales of magnification, the laparoscope under the operation automatically can be magnified with the appropriate scale in the decided workspace. To evaluate validity of this system, we conducted a laparoscopic cholecystectomy using an extracted pig liver with gallbladder. Operators in this study were two surgeons who experienced more than 50 cases of laparoscopic cholecystectomy. The operating time performed under the robotic assistant system was compared with that of under the support of the human camera assistant.

**[Result]** The operating time performed under the robotic assistant system was 20?1.4 min, whereas it was 27.5?9.2 min under the support of the human camera assistant. There was no significant difference between two groups (p=0.37).

**[Conclusion]** This pilot study performed that the motion of robotic assistant system was comparable that of the human camera assistant, and enabled smooth surgical operation. Thus, it was indicated that our robotic assistant system had a practicability sufficiently.

## Robotics - P521

**TWO CASES OF GASTROINTESTINAL STROMAL TUMORS DIAGNOSED BY TRANSRECTAL ULTRASOUND GUIDED PROSTATE BIOPSY: TREATMENT COURSE AND REVIEW OF LITERATURE**, ketul K Shah MD, Rahul k Thaly MD, Vipul R Patel MD, Department of Robotics and Computer assisted surgery, Division of Urology, Ohio State University, Columbus, Ohio

**Objective:** Gastrointestinal Stromal tumors (GIST) are the most common mesenchymal malignancy of the gastrointestinal tract. To our knowledge no cases have been reported in the literature diagnosed after a transrectal ultrasound (TRUS) guided prostate biopsy. We describe two cases diagnosed in such manner as well as their unique management
in the era of molecularly targeted therapy.

**Methods:** Case 1: A 61 year old male with a history of benign prostatic hypertrophy presented with increasing dysuria and urinary retention. The work up led to CT imaging that demonstrated a large 8 x 9cm pelvic floor mass arising from the prostate gland. Transrectal biopsy revealed a spindle cell neoplasm. Immunohistochemical staining was negative for prostate specific antigen (PSA), S-100, AE1/AE3, desmin, ER, PR, smooth muscle antigen (SMA) and Her2neu. Positive stains included CD117, CD34, CD31 (weak) all consistent with GIST. Serum tumor markers included PSA level of 0.7 ng/ml, carcinoembrionic antigen (CEA) of 0.6, and undetectable levels of CA 19-9. Mild renal insufficiency was noted due to bilateral hydronephrosis. After bilateral nephrostomy tube placement, Imatinib therapy was started with a plan for future tumor resection. The patient experienced prompt improvement in local symptoms and underwent a radical robotic assisted prostatectomy. The resected specimen showed no residual tumor (pathological complete response) and 14 months later the patient remains on imatinib without recurrence.

Case 2: A 61 year old male presented to a colorectal surgeon for the management of an anal fissure and irregular diffusely enlarged prostate was noted. His PSA was 0.4ng. TRUS guided prostate biopsy showed a spindle cell lesion consistent with GIST. Immunohistochemistry markers were positive for CD34 and CD117 and negative for SMA, AE1/AE3, and S100. Further imaging studies revealed a pelvic floor mass of approximately 7.7cm. The patient was initiated on neoadjuvant Imatinib therapy with excellent clinical and radiological response that a surgical intervention was feasible. A radical robotic prostatectomy and pelvic mass removal was performed. Pathological complete response was noted on the specimen.

**Conclusion:** The detection of GIST after TRUS guided biopsy in these two unusual cases highlights the treatable nature of these tumors, the importance of recognizing GIST in unusual locations and the need to seek neoadjuvant therapeutic options in non surgical candidates.

## Solid Organ Removal – P522

**LAPAROSCOPIC SPLENECTOMY: DOES GENDER PREDICT OUTCOME?, Severn G Barloco MD, Jonathan R Adkins MD, Stephanie Kreml MD, Vadim Sherman MD, John F Sweeney MD, Baylor College Of Medicine - Michael E. DeBakey Department Of Surgery**

**Introduction:** Laparoscopic splenectomy (LS) is a widely accepted treatment for both benign and malignant hematologic disorders. Evidence that age and obesity are predictive of outcomes for LS has previously been demonstrated. The current study was undertaken to evaluate the impact of gender on outcomes for LS.

**Methods:** A retrospective review of all patients undergoing LS at our institution was performed. Analysis included patient age, gender, body mass index (BMI), indication for LS, comorbidities, operative time, estimated blood loss (EBL), splenic weight, length of stay (LOS), time to tolerating oral intake (PO), and post-operative complications. Continuous data are expressed as mean ± [SD] and are analyzed by Students T-test.

**Results:** A total of 126 LS were performed between March 1996 and April 2006 (70 males and 56 females). Benign hematologic conditions were the indication for LS in 71% of females and 61% of males.

<table><thead><tr><th></th><th>Age<br>(Years)</th><th>BMI</th><th>OR Time<br>(Minutes)</th><th>EBL<br>(cc)</th><th>Splenic Wt<br>(Grams)</th><th>LOS<br>(Days)</th><th>PO<br>(Days)</th></tr></thead><tbody><tr><td>Male<br>(N=70)</td><td>54.2<br>[15.4]</td><td>29.6*<br>[6.6]</td><td>177.5*<br>[55.7]</td><td>689.0*<br>[978.3]</td><td>824.6*<br>[850.6]</td><td>5.0<br>[5.8]</td><td>2.7*<br>[2.5]</td></tr><tr><td>Female<br>(N=56)</td><td>48.4<br>[19.5]</td><td>27.6<br>[5.5]</td><td>141.6<br>[41.2]</td><td>270.8<br>[401.5]</td><td>414.4<br>[488.9]</td><td>3.6<br>[4.4]</td><td>1.7<br>[0.9]</td></tr></tbody><tfoot><tr><td colspan="8">[Standard Deviation]: * Significantly Different From Females. P&lt;0.05</td></tr></tfoot></table>

Males undergoing LS were significantly taller and heavier, and had higher BMIs when compared to females. In addition, males were found to have significantly larger splenic weights and longer OR times with more operative blood loss. The conversion rate was 21.4% in males and 8.9% in

females, and the complication rate was 27.1% in males and 12.5% in females. There were 3 mortalities in the male group (4.3%) and none in the female group.

**Conclusions:** Our data demonstrate that females undergoing LS have better outcomes when compared to males. This is likely due to a combination of patient size, splenic weight, and indication for surgery. Surgeons should be aware of these factors when performing LS in male patients and make every effort to minimize risk and improve outcomes.

## Solid Organ Removal – P523

**LAPAROSCOPIC ADrenaLECTOMY FOR THE TREATMENT OF ADRENAL TUMORS, Patricio Donnelly MD, Javier Salgado MD, Pavlos Papasavas MD, Philip Caushaj MD, Daniel Gagne MD, The Western Pennsylvania Hospital, Clinical Campus Temple University**

**Background:** Since laparoscopic adrenalectomy (LA) was first performed in 1992, the technique has gained wide acceptance and is now considered the standard of care for treating benign adrenal tumors. The role of LA for the treatment of malignant adrenal tumors is still controversial. We report our experience with LA.

**Methods:** Retrospective analysis of 18 consecutive LAs performed between July 1999 and September 2006. All cases were performed by three surgeons using a laparoscopic transperitoneal approach. One patient was approached with a laparoscopic hand assisted technique. Parameters studied included age, gender, length of stay, tumor size, histopathology, operative time, estimated blood loss, intraoperative and postoperative complications and conversion rate. The relationship between tumor size and operative time or estimated blood loss was determined using a Pearson correlation.

**Result:** Eighteen LAs were included (eleven right and seven left). The mean patient age was 55 years (range 17-71 years) and the female/male ratio 14/4. The mean operative time was 173 minutes (range 80-270 minutes). There were no conversions to open technique. The mean tumor size was 3.9 cm (range 0.8-9 cm). There were no deaths.

Intraoperative complications included 2 patients with bleeding which was controlled laparoscopically; one patient required transfusion. Postoperative complications included one patient with pneumonia and one patient with adrenal insufficiency. The length of hospital stay was 2.6 days (range 1-7 days). Pathological examination of the tumors revealed cortical adenoma (n=10), pheochromocytoma (n=3), metastatic disease (n=3), cortical hyperplasia (n=1), and a calcified vascular cyst (n=1). The primary origin of the metastatic lesions was lung, kidney and colon. There was no significant correlation between the tumor size and operative time (r=0.33) or estimated blood loss (r=0.25).

**Conclusion:** Laparoscopic adrenalectomy is a safe and effective technique for the treatment of adrenal tumors.

## Solid Organ Removal – P524

**LAPAROSCOPIC NEPHRECTOMY EXPERIENCE AT A COMMUNITY TEACHING HOSPITAL, Eric D Edwards MD, Cornelius Vulpe MD, Armando E Castro MD, George S Ferzli MD, Lutheran Medical Center**

Laparoscopic nephrectomy, either partial or radical, is considered to be an advanced level case. Due to the technical demands of laparoscopic nephrectomy these operations are typically performed at high volume academic medical centers. We report our experience with partial and radical nephrectomy at a community teaching hospital. A retrospective review of all nephrectomies performed at a single institution from March 2004 to July 2006 was performed. During this period, 7 partial nephrectomies and 30 radical nephrectomies were performed. Indications for surgery were: renal cell carcinoma (21 cases), complications from obstructive uropathy (7 cases), urothelial carcinoma (3 cases), transitional cell carcinoma (3 cases) renal leiomyoma (1 case), papillary adenoma (1 case), and oncocytoma (1 case). Mean patient age was 63.4 years (27-81 years). Twenty seven patients were male and ten patients female. Mean operative time was 130 minutes (90-165 minutes). Estimated blood
<figure><img src="image_190.png" /></figure>

SAGES POSTER ABSTRACTS

loss was 90 mL (5-150 mL). One case was converted to an open procedure for bleeding. One patient required blood transfusion post-operatively. No patient required re-operation. Post-operative complications included: ileus (2 patients), exacerbation of congestion heart failure (1 patient), and sepsis (1 patient). There were no mortalities. Mean length of stay post-operatively was 3.6 days (1-9 days). Our results are comparable to those achieved by higher volume academic centers.

Solid Organ Removal – P525

HAND-ASSISTED LAPAROSCOPIC SPLENECTOMY FOR HCV
POSITIVE PATIENTS WITH THROMBOCYTOPENIA, Michiya
Kobayashi MD, Ken Okamoto MD, Tsutomu Namikawa
MD, Takehiro Okabayashi MD, Kazuhiro Hanazaki MD,
Department of Surgery, Kochi Mwdical School

**Background:** Peg-Interferon treatment for hepatitis C virus (HCV) positive patients are promising, however it may be sometimes given up due to thrombocytopenia as the side effect. We perform hand-assisted laparoscopic splenectomy for HCV positive patients with thrombocytopenia.

**Patients and Method:** From March to July of 2006, we have performed hand-assisted laparoscopic splenectomy for 4 patients with portal hypertension due to HCV positive chronic liver disease. All patients were female with average age of 56 years old (50 - 65). The indications of the splenectomy for these patients were thrombocytopenia for 3 patients who were supposed to take a treatment with Peg-Interferon for HCV therapy, and gastric varices with thrombocytopenia due to hypersplenism for 1 patient. Patients were placed in the right semilateral position with the left side up. A 7cm medi-an skin incision was made in the upper abdomen and GelPortTM was placed for hand-assisted laparoscopic sur-gery. A 12 mm trocar was placed infraumbilically and addi-tional two ports were placed in the left abdomen. The spleen was mobilized with spatula type electric cautery and ultrasonic cutting and coagulating surgical device. During the mobilization, surgeon's left hand could make good oper-ation fields. The artery and vein were cut with LigaSureTM vessel sealing system at the splenic hilus without stapler. The spleen was put in a plastic bag and taken out through the median skin incision.

**Results:** The average operating time and blood loss were 159min (150 - 170) and 100g (30 - 180), respectively. The average spleen weight was 213g (110 - 350). The case of gastric varices who underwent splenectomy with Hassab operation stayed hospital for 21days after surgery due to ascites. The average hospital stay after surgery of other three cases was 10 days (9 - 11). One case showed high amylase level in the drained fluid, which became normal within 8 days.

The average platelet count before surgery was 59,000 /microl (40,000 - 60,000). That of 1st, 3rd, and 7th postopera-tive date were 66,000 /microl (47,000 - 80,000), 87,000 /microl (60,000 - 110,000), and 157,000/microl (91,000 - 216,000), respectively. All three patients could proceed to take Peg-Interferon treatment safely.

**Conclusion:** Hand-assisted technique for laparoscopic splenectomy was helpful for making good operation fields and safe even for patients with portal hypertension.

Solid Organ Removal – P526

EXPERIENCE WITH TRANSPERITONEAL LAPAROSCOPIC
ADRENALECTOMY, Misuzu Mori MD, Nobumi Tagaya
PhD, keiichi Kubota PhD, Second Department of Surgery,
Dokkyo Medical University, Tochigi, Japan

**Background:** Laparoscopic adrenalectomy for benign adre-
nal tumors has become the preferred surgical treatment,
however, for pheochromocytoma or metastatic tumor it is
still controversial. We report our experience with transperi-
toneal laparoscopic adrenalectomy.

**Materials and methods:** Recent eight years, we performed 30 transabdominal laparoscopic adrenalectomies in 10 males and 19 females. Their diagnoses were primary aldosteronism in 12 patients (40%), pheocromocytoma in 6 (20%), Cushing syndrome in 5 (16.7%), non-function in 5 (16.7%) and metastasis in one (3.3%), respectively. Their ages

ranged from 17 to 67 years with a mean of 35 years. The
location of tumor was right side in 8 patients (26.7%), left
side in 17 (56.7%), bilateral side in 3 (synchronous: 2,
metachronous:1) (10%) and Zucherkandle in one (3.3%),
respectively. Synchronous laparoscopic cholecystectomy
was performed in 3 patients (10%).

**Results:** There were no conversions to open surgery. The operation time and estimated blood loss ranged from 60 to 450 min (mean: 132 min) and 3 to 1200 ml (mean: 130 ml). None of the patients required transfusion. Only two bilateral patients of pheocromocytoma had two and four tumors. The mean diameter of the excised tumors was 23.3 mm (range: 8 to 90 mm). There were no postoperative complications. All patients became normal blood pressure and catecholamine levels without treatment. The mean postoperative hospital stay was 9 days (range: 3-15 days). The mean duration of follow up was 61.5 months (range: 1-123 months). There was no recurrence during the follow-up period.

**Conclusion:** Laparoscopic treatment for adrenal tumors is safe and effective procedure without major perioperative complications even in pheocromocytoma.

Solid Organ Removal – P527

LAPAROSCOPIC ADRENALECTOMY: A 6 YEAR NON-TERI-
TIARY CARE SINGLE CENTER RETROSPECTIVE STUDY.,
Biswanath Gouda MD, Thomas J Nelson MD, Jennifer I Lin
MD, Sunil Bhoyrul MD, Scripps Clinic, Torrey Pines, CA
92037

**Background:** Laparoscopic adrenalectomy is considered the gold standard for the removal of most adrenal tumors. We have been performing laparoscopic adrenalectomy at our institution since June 2000. We conducted a retrospective study to review our experience in the context of this surgery being performed outside a tertiary care center.

**Methods:** From June 2000 to Aug. 2006, 19 transperitoneal laparoscopic adrenalectomies were performed at the Scripps Clinic. All patients? charts were retrospectively reviewed for operative time, blood loss, complications, conversion to open surgery and hospital stay.

**Results:** The mean age was 50.6 years (range, 21-65 years) of which the majority were females (63.1%, n=12).

Indications were pheochromocytomas (36.8%), nonfunction-
al adenomas (31.5%), aldosterone-producing adenomas
(10.5%), adrenal hyperplasia (10.51%) and adrenal cyst
(10.51%). The median size of the tumors on abdominal CT
was 3.65cm (range, 1-9 cm) and median pathology reported
weight was 18.0 gm (range, 2-170 gm). Median time for
anesthesia was 146.5 minutes (range, 124-214 minutes), and
median operative time was 101.0 minutes (range, 91-148
minutes). Median estimated blood loss was 10.0 ml (range,
10-700 ml). There was no mortality, and post operative com-
plications occurred in 15.7% patients (n=3). Pulmonary
edema, retroperitoneal bleeding and anemia were the treat-
ed complications. A single patient, who developed pul-
monary edema at the onset of laparoscopy, was converted
to an open procedure. Preoperative medically treated hyper-
tension completely resolved in 63.6% patients (n=7) after the
surgery. The median length of hospital stay was 1.5 days
(range, 1-6 days).

**Conclusion:** This retrospective series demonstrates that a well trained and experienced surgeon in a non-tertiary care environment can demonstrate equivalent operative times, blood loss, complications, conversion to open procedures and hospital stays when compared to major tertiary care centers.

Solid Organ Removal – P528

HAND-ASSISTED LAPAROSCOPIC SPLENECTOMY: WHEN
SHOULD IT BE OFFERED?, Nathan Novotny MD, Don Selzer
MD, Indiana School of Medicine, Department of Surgery

**Background:** Laparoscopic splenectomy (LS) has been shown superior to open splenectomy (OS). Although rare, splenomegaly (splenic weight > 1000 g) presents unique challenges of loss of domain within the abdomen and manipulation of the organ due to its weight. Traditionally, OS has been offered to these patients. In an attempt to offer these patients a minimally invasive approach, hand-assisted
laparoscopic splenectomy (HALS) has been proposed as the solution without sacrificing the benefits afforded by LS.

**Methods:** A single surgeon's experience from 2003 to 2006 at an academic center was reviewed. Demographics, operative information, and perioperative data were compiled. Results: Eighteen patients underwent isolated splenectomy during that time period. Diagnoses included leukemia, lymphomas, hemophagocytic syndrome, sarcoidosis, myelodysplastic syndrome, hemolytic anemia, and myelofibrosis. Six patients underwent HALS, ten LS, and two OS. HALS and LS provided similar outcomes based upon estimated blood loss, operative time, time to oral intake, length of stay, and mortality. Three of 10 (30%) LS spleens weighed > 1000 g. Two of these 3 (67%) were converted to open. No LS with a spleen of < 1000 g was converted to open. Five of 6 HALS spleens weighed > 1000 gm. No HALS was converted to open. One-way analysis of variance demonstrates a statistically significant relationship between splenomegaly and CT splenic vein diameter (p=0.002), CT generated craniocaudal length (p=0.011), and palpable distance from costal margin (p=0.013).

**Conclusions:** HALS and LS have equivalent outcomes and are superior to OS. In our experience, LS for splenomegaly has a prohibitively high conversion rate and should be replaced with HALS for spleens predicted to be greater than 1000 g. Splenic weight is best estimated preoperatively by a combination of CT determined splenic vein diameter and length and the physical exam.

## Solid Organ Removal – P529

**OBESITY DOES NOT ADVERSELY AFFECT OUTCOMES AFTER LAPAROSCOPIC SPLENECTOMY**, Tracy S Pitt

DO, Brethauer Stacy MD, Sutep Udomsawaengsup MD, Chikunguwo Silas MD, Ballem Naveen MD, Chand Bipan MD, Rosenblatt Steven MD, Cleveland Clinic Foundation

**INTRODUCTION:** Obesity is considered a relative contraindication to laparoscopic splenectomy (LS) by many surgeons. The purpose of this study is to evaluate the surgical outcomes of LS in obese patients.

**METHODS:** A retrospective review of our LS database from 1995 to 2006 was conducted. Patients were classified according to BMI (Group A, BMI > 30 and Group B, BMI < 30). Our primary endpoints were conversion rate, complications (hemorrhage, infection, pancreatic injury, cardiopulmonary complications), length of stay, operative time, and estimated blood loss (EBL). Logistic and multiple regression analyses were performed to control for age, ASA classification, spleen weight, preoperative platelet count, and the diagnoses of idiopathic thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AHA), and lymphoproliferative disorders (LPD).

**RESULTS:** 246 LS patients were included in the analysis. The two groups showed no significant difference with respect to age, ASA, preoperative platelet counts or spleen size (p>0.05). There was however a difference with respect to the diagnosis of ITP and LPD (p<0.03). In group A (n=77) the average BMI was 36 (30-65). There were 7 (9%) conversions to open and 15 (19%) complications. Length of stay was 3.8 days, mean EBL was 229 mL, and the mean operative time was 158 minutes. Group B (n=169) had an average BMI of 24 (15-29). This group included 21 (12%) conversions and 31 (18%) complications. The average LOS was 4 days, EBL was 255 mL, and the mean operative time was 142 minutes. After controlling for ITP, LPD, and spleen size, there was no significant difference between obese and non-obese patients with regards to conversions or complications (p=0.26 and 0.8, respectively). Also, EBL and LOS were not significantly different between the two groups (p>0.6). OR time was longer for obese patients (p=0.003).

**CONCLUSION:** Obesity does not adversely affect outcomes after LS. Operative times were longer in obese patients however this did not affect conversion rates, complication rates, or LOS. The laparoscopic approach is the optimal technique for splenectomy regardless of patient weight.

## Solid Organ Removal – P530

**LAPAROSCOPIC HAND-ASSISTED SPLENECTOMY FOR MASSIVE SPLENOMEGALY**, Ram M Spira MD, Abi Vainstein MD, Vered Avidan MD, Joseph Alberton MD, Petachia Reissman MD, Department of Surgery, Shaare Zedek Medical Center (affiliated with The Faculty of Health Sciences, Ben-Gurion University of the Negev), Jerusalem, Israel.

**BACKGROUND** Laparoscopic splenectomy (LS) is the gold standard for normal-sized spleens, but is still controversial for massive splenomegaly (MS), mainly due to expected technical difficulty and increased risk of bleeding. The aim of this study was to assess the outcome of LS in patients with MS.

**PATIENTS and METHODS** We reviewed all consecutive patients who underwent LS for MS in the department of surgery, Shaare-Zedek Medical Center during 2002-2006. Massive splenomegaly was defined as weight >700 gr. We used a total laparoscopic (TL) or hand assisted (HALS) technique.

**RESULTS** 20 patients underwent LS for MS [12 males, 8 females, mean (range) age 50 (6-76) years]. Indications were: Myelofibrosis- 5, Lymphoma- 4, Spherocytosis- 3, Polycytemia Vera- 2, Reactive splenomegaly- 2, Thalassemia- 1, Tuberculosis- 1, Myelodysplastic syndrome- 1, and ITP+CLL- 1.

The technique was TL in 6 patients and HALS in 15. Mean (range) splenic weight was 1715 (915-3200) gr. for the entire study group, 1460 and 1749 gr. for the TL and HALS groups, respectively.

Mean (range) operative time was 189 minutes (83-340) for the entire study group, 157 and 202 minutes for the TL and HALS groups, respectively.

Median (range) PRBC transfusion was 2 (0-20) units.

Intra operative bleeding occurred in 5 patients all of which occurred in the HALS group. One case was converted to an open procedure. We believe that most of these bleeding events would have required conversion to an open procedure if the hand was not in the abdomen to allow rapid control of the bleeding.

Median length of hospital stay was 8 days.

Postoperative major complications (sepsis, bleeding) occurred in 8 patients.

One patient died 6 weeks after surgery due to pulmonary leukosequestration and respiratory failure.

**CONCLUSIONS**

Laparoscopic splenectomy in splenomegaly is feasible and safe in experienced hands. The use of the Hand-Assisted technique in massively enlarged spleens is the preferred technique in our experience.

## Solid Organ Removal – P531

**CLINICAL, ANATOMIC AND PATHOLOGIC PREDICTIVE FACTORS FOR INMEDIATE SURGICAL OUTCOME AFTER LAPAROSCOPIC SPLENECTOMY IN CASE OF SPLENOMEGALY**, R D Targarona MD, EM Targarona MD, JC Pernas MD, L Pallares MD, C Balague MD, Gich I MD, M Trias MD, Service of Surgery, Radiology* & Epidemiology**. Hospital Sant Pau, Autonomous University of Barcelona. Barcelona, Spain

Laparoscopic approach has become the surgical choice for splenectomy (LS), but some controversies exist about its definitive role in case of splenomegaly. Factors that may impact immediate outcome are clinical (type of disease, plat. count), but also of anatomic and pathological nature due to the size and volume of the spleen and the difficulty for its intrabdominal manipulation.

**Aim:** to evaluate the predictive value of clinical and anatomic factors on immediate outcome after LS in cases of splenomegaly.

**Material & methods.** We reviewed from a prospective data base all the patients submitted to LS with a final spleen weight > 800 g, in which a previous CT scan were also available. 3D reconstruction of the spleen was performed, and spleen volume and main spleen (AP, Lat-lat, Craneo.caudal) and abdominal cavity diameters were measured (3D Doctor

<figure><img src="image_191.png" /></figure>
<figure><img src="image_192.png" /></figure>

# SAGES POSTER ABSTRACTS

software). Age, sex, BMI, platelet count, and diagnosis (benign/malignant) were also recorded. Dependent variable were op time, bleeding, conversion and stay. Univariate and multivariate analysis was performed (SPSS).

**Results.** This series included 39 pts, 18 m and 21 f, 59+15 y.; 7 benign and 32 malignant. Conversion: 15%, op time: 140? (90-300), Morbidity: 15%, bleeding: 50 cc (0-1000), Stay: 5 d. (3-22). Multivariate analysis showed that factors predictive for conversion were: mediolateral spleen diameter and platelet count. For intraop bleeding, predictive factor was spleen volume. Ant-post spleen diameter was related to op. time, but the main factor related to postop morbidity was age.

**Conclusion:** Local anatomy and clinical factors directly affect surgical outcome in LS for massive spleen. Spleen volume and ant?post and medio-lat diameter were predictive factors for intraoperative outcome, but only age was related to postop morbidity. These factors should be taken in account when planning this kind of procedures

## Solid Organ Removal – P532

**LAPAROSCOPIC SPLENECTOMY FOR SPLENIC MASSES, D J Tessier MD, L M Brunt MD, R Pierce MD, V Halpin MD, J C Eagon MD, M M Frisella RN, J Czerniejewski, B D Matthews MD, Washington University School of Medicine**

**Introduction:** The purpose of this study is to evaluate peri-operative outcomes and pathology in patients undergoing laparoscopic splenectomy for splenic masses.

**Methods:** The records for 174 patients undergoing laparoscopic splenectomy from 5/94-8/06 were reviewed. Patient demographics, preoperative imaging, EBL, OR time, spleen size, intraoperative/postoperative complications, LOS, pathology, and 30-day mortality were extracted. Data are mean ± SD. Statistical significance (p<0.05) was determined using two-tailed t-test and Fisher's exact test.

**Results:** A splenic mass was diagnosed preoperatively in 18 (10.3%) patients, 7 males and 11 females. Mean patient age was 51.4 yrs ± 13.7, mean ASA 2.3 ± 0.8 and mean BMI 27.3 kg/m2 ± 5.8. CT scans demonstrated splenic masses in all patients. The mean mass size was 4.3 cm ± 3.3 cm (range 1.0 - 11.0 cm). Three patients had numerous splenic masses. Mean spleen length was 14.6 cm ± 7.5 (range, 5.5-40.2). Six patients had FDG-uptake on PET scans. Totally laparoscopic splenectomy was completed in 15 patients and hand-assisted splenectomy in 3 patients (2 planned hand-assist, 1 converted). Mean OR time was 128.3 min ± 38.5 and mean EBL was 110 ml ± 137.5. Mean splenic weight was 288.2 gm ± 252.2. There were no intraoperative complications or 30-day mortalities. Postoperative complication rate was 11.1%. Mean LOS was 1.9 days ± 1.0. Pathology was malignant in 6 (33.3%) patients (n=5 lymphoma; n=1 adenoCA) and benign in 12 (66.6%) patients (n=4 pseudotumor, lymphoid/granulomatous hyperplasia; n= 4 cystic mass; n=1 hamartomas; n=2 hemangioma; n=1 angioendothelioma). There were 3 false positive PET scans. In comparison to 73 patients undergoing laparoscopic splenectomy for ITP, there was no significant difference in mean EBL, OR time, conversion rate, intraoperative complication rate or LOS. The postoperative complication rate was 11.0% (p=0.5) and 30-day mortality rate 1.3% (p=0.8) for patients with ITP.

**Conclusions:** Laparoscopic splenectomy is appropriate for patients whose indication for surgery is splenic mass. Suspicious splenic masses should be removed due to the relatively high incidence of malignant pathology (33.3% in this series), most commonly lymphoma.

## Thoracoscopy – P533

**THORACOSCOPIC SURGERY. OUR EXPERIENCE., Jose Manuel Hernandez Gutierrez MD, Miguel Angel Martinez Alfonso MD, National center for endoscopic surgery We are carried out descriptive, observational work, in the national center for endoscopic surgery, in Havana, Cuba. The period of time understood between 1995 and 2005. The objective was to evaluate our results in connection with the reach of the specialty in the current moment. For they are**

compared it the results of our group with this technique with the best results that they are reported in the literature and that in turn they contribute outstanding scientific evidence. We were carried out in our center a total of 237 interventions, of them 54 with diagnostic ends and 183 for therapies. The carried out surgeries were the following ones: Parietal Pleurectomias 55, dorsal simpatectomias 30, bulectomia for emphysema 28, empiema 26, vagotomia transtórácica 19, exéresis of mediastinal tumors 12, pericardic windows 9, exéresis of pleural mesotelioma 2 and ruled lung resections 2. Our time surgical average was of 65 minutes with a range from 20 to 150 minutes. The use of pleural drainage in 65% and their permanency average of 38 hours. The uses of preoperative intercostal analgesia in the place of the thoracoport exchanging in 95% of the cases and the use of analgesic postoperative was of a dose in 100%, of 2 dose in 51% and of 3 dose in 9% of those operated. The postoperative morbidity was not significant, being only needed of a reintervención (empiema pleural that doesn't solve). The demurrage average of 3 days with a range from 2 to 5 days and the mortality of 0,4%, given by a deceased that presented massive bled later to an inferior lobectomy.

## Thoracoscopy – P534

**EVALUATION OF COMPENSATORY SWEATING AFTER BILATERAL THORACOSCOPIC SYMPATHECTOMY FOR PALMAR HYPERHIDROSIS., Leonid Lantsberg MD, Shai Libson MD, Boris Kirshtein MD, Solly Mizrahi MD, Department of Surgery ?A? Soroka University Medical Center**

Faculty of Health Sciences Ben Gurion University of the Negev, Beer Sheva, Israel

**OBJECTIVE:** Compensatory sweating (CS) is the most common side effect of thorascopic sympathectomy (TS) and considered the main cause of patient discontent. We investigated the extent and severity of CS following TS in patients suffering from palmar hyperhidrosis (PH).

**METHODS:** We performed a retrospective review of 60 patients undergoing bilateral T2-T3 TS for PH in our department between 1997 and 2003. The study was based on a telephone questionnaire and medical chart review. 40 patients (67%) replied to the questionnaire and were included in the study. Postoperative complications, therapeutic results, patient satisfaction and the severity of CS were assessed.

**RESULTS:** In all patients both palms were dry at the end of surgery. Postoperative complications included permanent unilateral Horner's syndrome, wound infection and residual pneumothorax resolving after thoracal drainage in 1 patient each. CS with different severity occurred in 35 patients (87.5%). 6 patients (15%) regretted undergoing the operation due to the extent and severity of the CS affecting seriously their quality of life.

**CONCLUSION:** TS is a simple procedure with a high success rate. However, CS is a serious complication and in a significant number of patients may cause regret of undergoing the operation, and therefore a careful selection of patients and comprehensive explanation are advisable.

## Thoracoscopy – P535

**THORACOSCOPIC RESECTION OF THE ECTOPIC MEDIASTINAL PARATHYROID ADENOMA, Masahide Murasugi PhD, Toyohide Ikeda PhD, Takuma Kikkawa MD, Tamami Ikasa MD, Toshihide Shimizu PhD, Kunihiro Oyama PhD, Masahiro Mae PhD, Takamasa Onuki PhD, First Department of Surgery, Tokyo Women?fs Medical University**

(Background) Patients undergoing long-term hemodialysis often suffer from secondary hyperparathyroidism. Most mediastinal parathyroid adenomas can be resected with a transcervical approach, median sternotomy or thoracotomy. We present to describe our 0experiences in which video-assisted endoscopic surgery using thoracoscopy or mediastinoscopy was effective in treating patients with mediastinal parathyroid adenomas.

(Subjects and Methods) We treated 8 male and 13 female patients using video-assisted endoscopy to resect ectopic
mediastinal parathyroid tissues between July 1996 and April 2006. The patients ranged in age from 38 to 76 years.

**(Results)** Eighteen patients had undergone surgical treatment of hyperparathyroidism by the cervical approach to resect the four cervical parathyroid glands during their previous operation, but signs and symptoms associated with hyperparathyroidism recurred and PTH level increased during follow-up. In these patients, chest CT revealed masses in the mediastinal space, and technetium 99m MIBI scintigraphy revealed hot spots. In another patient, pre-operative MIBI scintigraphy revealed hot spots in the four cervical parathyroidal glands and a hot spot suggestive of an ectopic parathyroid gland in the mediastinal space. During the previous surgery, the four cervical parathyroid glands had been removed using the conventional approach and the ectopic gland was removed with the endoscopic technique. Ectopic mediastinal parathyroid glands were resected using video-assisted thoracoscopy or mediastinoscopy. Duration of operation ranged from 45 to 145 minutes. Mean blood loss was 25 mL and mean duration of hospitalization after operation was 5 days.

(Discussion) Many ectopic parathyroid adenomas can be removed by the cervical approach only, but some ectopic tumors in the mediastinal space cannot be accessed with this approach. Such patients have had to undergo median sternotomy or conventional thoracotomy. In the cases considered here, we were able to resect mediastinal parathyroid adenomas using video-assisted thoracoscopy or mediastinoscopy. In order to obtain successful results using the video-assisted technique, it is very important to specify the positions of ectopic parathyroid glands by preoperative MIBI scintigraphy and chest CT.

## Thoracoscopy – P536

### DEVELOPMENT OF NON-CONTACT SENSING SYSTEM DURING VIDEO-ASSISTED THORACIC SURGERY (VATS),

Masazumi Okajima MD, Yoshihiro Miyata MD, Masanori Yoshimitsu MD, Koichi Akayama MD, Tomohiro Kawahara, Chisashi Toya, Makoto Kaneko, Toshimasa Asahara MD, Hiroshima University

**Aim:** VATS procedures are often available to extirpate small pulmonary nodules. The disadvantage of VATS is the lack of tactile capacity. We have a hard time to detect such small pulmonary nodules during the VATS procedure, especially when they are located some depth from the lung surface. To supplement the lack of tactile capacity during VATS procedures, we developed a noble non-contact tactile sensor where an air jet is shot to the lung tissue so that we can extract the displacement pattern of the stiff point.

**Methods-Results:** We first developed an imager which consists of an optical fiber distance sensor and an air nozzle that produces an air jet to determine the deformity of the object. A right upper lobe of the lung was removed surgically from a lung cancer patient. The lung tissue was examined for stiffness by measuring the displacement distance following an air jet shot. The peak displacement distance reached 5 mm at a normal lung tissue, whereas it reached 3 mm at the tumor, indicating that the tumor is much stiffer than a normal lung tissue. Because the displacement of the object is measured based on the relationship between the reflected light quantity and the distance, the color of the object and the inclination angle of the tissue will affect the result. To

overcome this problem, we changed measurement system based on phase differential technique, where an air pulse jet was used instead of a single step force input. The developed sensor is composed of an air nozzle and optical fibers based distance sensors. For an air pulse jet (40Hz), sensors provide us a sinusoidal output with an individual phase. The sensor was scanned on the silicon rubber with a plastic ball. The outputs from optical fiber sensors change due to the existence of the ball. By Lissajous patterns, we can clearly observe the change of the phase from the change of its shape. The measurement was not affected by the color and inclination angle of the tissue. Recently, we made the animal model embed a several mm sized plastic ball in the living lung. Even in this living animal model we achieved to detect the plastic ball by this non-contact tactile sensor.

**Conclusion:** Non-contact tactile sensor based on phase differentiation is feasible for a diagnosis of pulmonary nodules during VATS procedure.

## Thoracoscopy – P537

### THORACOSCOPIC ENUCLEATION OF GIANT SUBMUCOSAL TUMOR OF THE ESOPHAGUS: A CASE REPORT,

Chadin Tharavej MD, Patpong Navicharoen MD, Suppa-at Pungpapong MD, Department of Surgery, Chulalongkorn University, Bangkok THAILAND

Open thoracotomy with tumor enucleation has been the standard treatment of symptomatic leiomyoma of the esophagus. Recently, the safety and feasibility of thoracoscopic approach has been reported by many investigators. However, the vast majority of tumor size was less than 5 cm. We report herein the feasibility and safety of thoracoscopic enucleation of giant submucosal tumor of the esophagus.

**A Case report:** A 27 year-old female presented with intractable chest pain and dysphagia for 3 and a half years. She has been previously diagnosed of panic disorder and treated with anti-anxiety medication for quite a long period without improvement. Finally, she underwent UGI endoscopy because of her worsening dysphagia. On examination, a large submucosal mass was found on mid part of the esophagus compromising about 60% of esophageal lumen. Computerized scan of her chest revealed 8 by 6 cm soft tissue mass on the right posterior wall of middle third of the esophagus compatible with leiomyoma.

Thoracoscopic approach for tumor enucleation was done using a 4 port technique. Mediastinal pleural and muscular layer over the tumor was incised. Tumor was successfully removed without mucosa tearing. Muscular layer defect was repaired using a running stitch. Tumor was put into a plastic bag and cut into multiple pieces before removal from the thoracic cavity. The operative time was 132 minutes and estimated blood loss was 150 ml. Postoperative period was uneventful. Patient can have regular food on day 4 after surgery. Her chest pain and panic disorder were completely resolved. Unfortunately, pathological examination revealed low grade leiomyosarcoma in one piece of the tumor. Esophagectomy was offered to the patient.

**Conclusion:** Thoracoscopic enucleation of giant submucosal tumor of the esophagus is feasible and can be safely performed. More experiences are needed to confirm this conclusion.
<figure><img src="image_193.png" /></figure>

## ET001

**NEW DEVICE FOR CLOSURE IN TRANSLUMINAL SURGERY,**
Kenneth Horton MS, Peter Hathaway, Gregg Krehel MPA, Eric Taylor BS, U.S Surgical, Auto Suture, Tyco Healthcare

**Objective:** Natural Orifice Transluminal Endoscopic Surgery (NOTES) involves the technique of performing abdominal surgery through an incision in the digestive tract such as the stomach or colon. Endoscopes are passed through the luminal incision and both diagnostic and therapeutic interventions have been reported in animal models including transgastric organ resection.

A fundamental challenge and potential barrier to the adoption of NOTES includes a secure and reliable closure method. While animal work to date would suggest that a puncture site can be closed with clips, the integrity of this closure method is suspect.

The ASGE/SAGES White Paper on NOTES suggests that the ability to suture intralumenally would offer maximum flexibility for the clinician. The aim of this study was to assess the technical and clinical feasibility of an endoscopic suture device.

**Technology and Method:** A porcine model was used for an endoscopic guided, intra-gastric exploration. An endotracheal intubation tube was used to deploy an endoscope, a flexible, articulating grasper and an endoluminal suturing device, with an end effector similar to the ENDO STITCH™ suturing product. This unique 7 mm flexible suturing device has a distal end which articulates thru a broad range, to orient the device for a precise tissue bite. Its jaws are similar to those found on US Surgical's laparoscopic ENDO STITCH™ product. The needle penetrated the tissue and the mechanism consistently transferred the needle and suture between jaws with ease. This configuration allowed for placement of a running or interrupted suture. Tissue manipulation was assisted by a 5 mm flexible, articulating grasper.

**Preliminary Results:** The use of this flexible suturing device is technically feasible, and enables the clinician to place sutures into the gastric wall.

**Conclusion:** A System that can offer this level of flexibility, precision and manipulation shows great promise in addressing the challenges of endoluminal closure, and warrants further investigation.

## ET002

**ENDOSCOPIC STAPLED GASTROPLASTY FOR THE TREATMENT OF MORBID OBESITY,**
Brent W Miedema MD, Jacques Deviere MD, Steven Edmundowicz MD, Roger de la Torre MD, Steven Scott MD, University of Missouri

**Objective:** To develop a totally endoscopic technique to construct a proximal gastric pouch with a restricted outlet. This restrictive gastroplasty may avoid the complications and morbidity associated with laparoscopic weight loss techniques.

**Description:** The transoral gastroplasty system ("TOGaTM System") made by Sat�ety, Inc. has two disposable stapling devices (a sleeve stapler and a restrictor stapler) that are placed under endoscopic view. Both staplers have a handle, a flexible shaft, and a rigid portion near the tip where the stapler assembly is located. A 19 mm sleeve stapler is placed transorally into the stomach over a guide wire. The sleeve stapler rotates open its jaws where the cartridge and anvil of a linear stapler are imbedded. A vacuum chamber is located in each jaw. A septum between the jaws directs the correct tissue into the suction chamber. Suction is applied, a portion of the anterior and posterior stomach is included in each vacuum chamber respectively, the septum is removed, and the stapler is closed and fired. The staple line has three rows of titanium staples and is 45 mm in length. This creates a transmural staple line (with serosa to serosa apposition) connecting the anterior and posterior stomach beginning at the angle of His and extending distal, parallel to the lesser curvature. A second more distal staple line is also placed to create an 80-90 mm sleeve, approximately 19 mm in diameter. The sleeve outlet is then constricted using a 25 mm linear stapler whose jaws open like an alligator. The restrictor stapler also uses a vacuum to acquire the tissue

and provide a full thickness staple line that forms a pleat and narrows the pouch outlet. The restrictor stapler is fired two to four times to create a 10-12 mm outlet. This completes a restricted gastroplasty along the lesser curvature of the proximal stomach similar in size to gastric pouches created with open or laparoscopic bariatric procedures. An animation and actual video of the procedure will be presented.

**Results:** This system has been used in 24 morbidly obese patients. The procedure is safe and results in significant weight loss for most patients. Clinical results are being presented in the plenary session.

**Future:** An FDA application will be made to perform a trial in the US to prove safety and efficacy. This is the first endoscopic stapler treatment for morbid obesity that has been used in man. This system holds promise as a safer treatment for obesity.

## ET003

**ROBOT ENGINEERED SKIN CLOSURE UNASSISTED ENVIRONMENT,**
Michael Kia DO, Lucy King PhD, Corneliu Rablu PhD, Kettering University, Mclaren Regional Med Ctr

**Objective** - The goal of the Robot Engineered Skin Closure Unassisted Environment (RESCUE) project is to design, prototype and fabricate a safety conscious, vision-driven automated robot system for closing a skin laceration with surgical staples.

**Description** - The robot system is fitted with a unique sensor feedback end-effector (for short - gripper), and integrated with a vision system powered by high resolution image processing algorithm. The system will apply local anesthesia and irrigate the laceration and staple without the presence of a physician. Although seam tracking has been used in hard-surface components manufacturing such as robotic welding, the seam recognition algorithms are not sufficient to apply to soft tissue and ill-defined skin profiles in the lacerated areas. This project hinges on developing a specialized image processing algorithm.

**Result** - To date, prototype models of the end-effector system have been developed as well as early trials of the vision algorithm.

<figure><img src="image_194.png" /></figure>

**Conclusion** - The end product will be a well tested, well documented, safe RESCUE system which, when presented with a laceration, will locate, identify, determine the approach for skin closure and perform the skin closing (stapling) operation. This type of technology can be implemented in the emergency departments for management of simple lacerations as well as integration into the military &x93;Trauma Pod&x94; project.

## ET004

**SINGLE SITE ACCESS FOR FLEXIBLE LAPAROSCOPIC SURGERY,**
Michael J Norton MD, Noel Ischy BS, Axcess Instruments

**Objective:** Describe a small, transabdominal, single site, multichannel access port which provides a stable platform for a flexible endoscope and instrumentation necessary to perform common operations such as appendectomy, cholecystectomy, and oophorectomy. **Description:** The transaxial single site port utilizes divergent, nonparallel and nonintersecting channels in a conical housing. One channel accepts 5mm straight instruments and one curved channel accepts an approximately 5mm flexible endoscope with a working channel. The device is small, measuring 12 mm at the entry point into the abdominal cavity. Minimal diameter of the housing is maintained by a gentle curve in the endoscopic channel to maintain a position close to the straight instrument channel. The port is placed in proximity of the target organ using an open technique. A flexible endoscope with a working channel is introduced into the curved channel and retroflexed to view the operative field. Triangulation and scope of field are preserved by the orientation of the chan-
nels. An instrument is introduced into the straight channel and a second instrument is placed through the working channel of the endoscope. The target organ is grasped or retracted and the operation is performed. The specimen is removed through the incision. Results: A prototype model has been designed for manufacturing and subsequent testing in an animal laboratory. Conclusions: The concept of a transaxial multichannel access port may present an opportunity to perform common operations through a single small incision. Laboratory evaluation is necessary.

## ET005

**DATA FUSION FOR VIRTUAL BILARY AND PANCREATIC ENDOSCOPY GENERATED BY OSIRIX AND CO2 MDCT**
**CHOLNGIOPANCREATOGRAPHY** Maki Sugimoto MD, Hideki Yasuda MD, Keiji Koda MD, Masato Yamazaki MD, Tohru Tezuka MD, Chihiro Kosugi MD, Yoshihisa Watayo MD, Shuji Naka MD, Teikyo University Chiba Medical Center

**Purpose:** Data fusion technique is a most recent virtual navigation system. We describe a new data fusion technique of CO2 MDCT enables synchronous visualization of biliary and pancreatic anatomy and abdominal vessels to provide real time navigation for digestive surgery. Our MDCT technique using carbon dioxide (CO2) gas as a negative contrast agent for hepato-pancreato-biliary assessment provides image-guided virtual endoscopy

**Methodology:** MDCT was performed in 50 HPB patients under trans-papillary infusion of CO2. Synchronously intra-venous contrast material was applied for virtual CT-Angiography. Postprocessing these data, we generated virtual endoscopy (cholangioscopy and pancreatoscopy) with arterio-cholangio-pancreatography (CMCPA). DICOM viewer OsiriX based 3-D reconstructions were incorporated on display in the operating room during surgery by surgeons. Moreover, these data were preview on the patient body surface and operative field by projector. Capability of these pre- and intra-operative virtual navigations using data fusion of virtual endoscopy and CMCPA was evaluated.

**Results and discussions:** CMCPA provided accurate information for localizing the target lesions of HPB benign and malignancies with its relationship to the surrounding vessels compared with open laparotomy without any complications. This procedure could help improve surgical prognosis.

**Conclusion:** Data fusion by OsiriX and synchronous fusion CMCPA provide useful intraoperative real time 3-D navigation for detailed planning operation in complex HPB surgeries.

<figure><img src="image_195.png" /></figure>

## ET006

**COMPUTER ASSISTED ENDOSCOPY,** Amir Belson MD, Neoguide Systems

Flexible endoscopy is routinely used in medicine for diagnosis and treatment of hollow organs. The flexibility of those devices enables them to be inserted into a non-straight path or tortuous organ by pushing the scope against and applying forces to the walls of the organ. Most of the flexible scopes have a steerable tip that is controlled by the operator according to images transmitted from a camera in the tip. However, the shaft of a flexible endoscope is under no control.

Rigid endoscopes, on the other hand, provide a stable platform for surgical interventions but do not change their shape and therefore cannot be used to inspect tortuous organs or be inserted through a non-straight path.

NeoGuide Systems is developing a computer-assisted flexible endoscope that can traverse a tortuous path without applying forces to the walls. When active, it is more rigid than the conventional flexible scopes, enabling it to serve as

a stable platform for tools delivered through the scope's working channel.

NeoGuide's technology measures the tip's depth of insertion the tip's position in space - as instructed by the operator. Combing the two, enables the system to build a numerical three dimensional map that can be converted to a graphical map. The shaft of the endoscope consists of multiple segments in addition to the user-controller tip. These segments are controlled by the computer, which directs each segment to assume the shape that the tip had at the same depth of insertion.

In conventional colonoscopy, the scope is pushed against the wall of the colon - which leads to stretching of the wall and the mesenteric tissues. This phenomenon, known as looping, is one of the major reasons for the difficulty of the procedure and the pain associated with it. NeoGuide's initial product is a computer-assisted colonoscope designed to deal with this problem. The system was cleared by the FDA in 2006. and is expected to be commercially available in 2008.

The second application that could potentially benefit from NeoGuide's computer-assisted endoscopy technology is Natural Orifice Transluminal Endoscopic Surgery (NOTES) where the system that delivers the tools needs to be advanced to the correct location, often in a path that runs between organs in a non-straight fashion and then positioned in the correct place relative to the surgical field and serve as a stable platform for the tools.

Pre-clinical NOTES studies will be performed in the near future.

## ET007

**BALLOON MICROWAVE CATHETERS FOR ABLATING SOLID TUMORS AND FORMING CAVITIES FOR THE LOCAL DELIVERY OF THERAPEUTIC AGENTS,** Francis E Rosato MD, Thiru Lakshman MD, Ernest L Rosato MD, Arye Rosen PhD, Fred Sterzer PhD, Thomas Jefferson University

Balloon Microwave Catheters for Ablating Solid Tumors and Forming Cavities for the Local Delivery of Therapeutic Agents.

Francis E. Rosato Jr, Thiru Lakshman, Ernest L. Rosato, Arye Rosen, and Fred Sterzer. Thomas Jefferson University, Philadelphia Pa

**Objective:** This study was designed to evaluate the ability of balloon microwave catheters to rapidly ablate tissue and form a residual cavity allowing for the instillation of therapeutic agents.

**Description/Methods:** All experiments used a balloon catheter by Angiodynamics. Flourescin isothiocyanate dextran (FID) solution was injected under pressure into the cavity created by the balloon ablation. The penetration of dextran was evaluated using ultraviolet light during sectioning of the tissue. Balloon microwave catheters with internal reflectors were also used. In vitro studies were carried out in beef liver and in vitro studies were carried out in pig livers.

**Preliminary Results:** Cylindrical shaped necrotic lesions with a diameter of 3.0 cm and length of approximately 4.5 cm could be produced in vivo for a 3 minute ablation with 100 watts of 915 MHz microwave power without carbonizing any of the tissues surrounding the balloons. Lasting hollow cavities formed in the ablated tissues around the catheters closely approximated the shapes and sizes of the expanded balloons. When fluorescent dextran was introduced into these cavities under pressure the solution penetrated to the margins of the ablated tissue. Using balloon catheters with internal microwave reflectors it was possible to preferentially heat tissues in only one direction.

**Conclusion/Future:** Balloon microwave catheters appear to be well suited for the treatment of solid malignancies. They rapidly and uniformly ablate large volumes of tissue. Furthermore, these catheters can create reservoirs for anticancer agents in the ablated tissues that can be forced through the destroyed malignant tissues to the margins of the ablations where they can act against any remaining viable malignant cells, that if not destroyed could lead to recurrences of the cancer.
<figure><img src="image_196.png" /></figure>

## ET008

AN INFRARECT DENDROSCOP FOR ENERGISED LAPAROSCOPIC SURGERY, Chengli Song PhD, Benjie Tang PhD, Paul Campbell PhD, Tim Frank PhD, Alfred Cuschieri PhD, University of Dundee

**Objective:** A novel infrared endoscope has been developed to investigate the thermal spread and collateral damage during energized laparoscopic surgery.

**System and Method:** The infrared endoscopic system consisted of an endoscope measuring 10 mm in diameter and 30 cm in length. The endoscope is directly coupled to an advanced Cedip mid-infrared (3-5 µm) thermal camera, which has a focal plane array of 320 by 240 pixels, and a thermal sensitivity of 0.02C.

The system was evaluated in a standard laparoscopic surgery trainer with the aim of detecting thermal spread during laparoscopic energised dissections. Cutting and coagulation procedures were conducted on pig stomach using HF electrosurgery, AutoSonix scalpel and LigaSure vessel sealing system. Digital and thermographic videos were taken for advanced thermal analysis and image processing.

**Results:** During the energized cutting and coagulation experiments, thermographic measurement showed that the average thermal spread was 4.2 mm above 45C with the LigaSure, and the exposed instrument surface at the tip developed a temperature of approximately 100C. The LigaSure Atlas 10 mm laparoscopic device exhibited a superior performance with only 2.3 mm thermal spread and with a maximal temperature on the jaws well within tolerable limit 35C. The AutoSonix dissection device caused a bigger thermal spread of 5.3 mm. During HF electrocoagulation temperatures reaching 275C were observed.

**Conclusions:** The study has confirmed that infrared laparoscopy is able to monitor thermal profiles in tissues during energised dissections in real-time. It thus has the potential to increase the safety of laparoscopic dissections when used as an adjunct to white light laparoscopy.

## ET009

HIGH DEXTERITY INSTRUMENTATION IN LAPAROSCOPIC SURGERY, Paul G Curcillo II MD, Drexel University College of Medicine, Dept of Surgery

Laparoscopic surgery has clearly minimized the incisions and discomfort associated with standard open surgery. In addition, the range and complexity of procedures now performed cover the entire range of General Surgery, Urologic Surgery, Gynecologic Surgery and Thoracic Surgery. Until recently, the limitations on laparoscopy were mostly secondary to the rigidity of the instrumentation. Introduction of initial articulating devices demonstrated the clear need to reintroduce freedom of movement at the end effectors of laparoscopic instruments.

RealHand™ laparoscopic instruments represent a new device category termed High Dexterity (HD) instrumentation. Functioning through a patented series of proximal to distal cables and links allows for the unique movement and control of the end of the instrument with simple wrist action. This novel line of hand-held MIS instruments provides dynamic articulation with 7 degrees of freedom of movement. RealHand™ allows the instrument tip to mirror all hand movements, providing robotic-like maneuverability without the need or cost of complex hardware.

A series of colonic resections (right, transverse, sigmoid and near-total proctocolectomy), gallbladder surgeries and abdominal adhesiolysis have all been successfully completed using one High Dexterity Instrument along with a standard rigid laparoscopic instrument. All procedures were accomplished using two instrument ports and one camera port (three total ports). Total operative times, results and outcomes are comparable to standard laparoscopy. No extra training, set-up time or port placement limitations have

been experienced.

This novel High Dexterity instrumentation allows for adaptability to any position within the abdomen, allowing any necessary angle of approach, virtually removing constraints of standard port placement positions. In addition, procedures involving more than one quadrant or total abdominal access are easily approached secondary to the simple articulation and control mechanisms.

Additional applications in endoscopy may demonstrate adaptability to the emerging NOTES procedures.

## ET010

VAGAL BLOCKING FOR OBESITY CONTROL (VBLOC THERAPY), Mark B Knudson PhD, Adrianus Donders MS, Mark Stultz MS, EnteroMedics St. Paul, MN US

**1) Objective of the technology**

The objective of VBLOC Therapy is to foster weight loss in persons with obesity by intermittently blocking the anterior and posterior vagal trunks at the level of the esophagogastric junction. Vagal BLocking for Obesity Control (VBLOC) Therapy utilizes an implanted neuroregulator to deliver very high frequency, low energy electrical pulses to block afferent and efferent vagal activity. The objective of offering rechargeable as well as RF system neuroregulators is to maximize patient choice and quality of life.

**2) Description of the technology and method of its use.**

The use of neuromodulation systems that incorporate implantable power sources has been previously reported by one of the authors to foster greater improvements in patient quality of life when compared to the use of RF-coupled (externally powered) systems. Because RF systems utilize an external power source, they can be made smaller than rechargeable systems, but they require continuous wear of an external device for therapy delivery. The rechargeable technology in development incorporates an implanted lithium ion rechargeable power source that requires once weekly, rather than continuous, wear of an external device; in the case of the rechargeable system, the external device provides ambulatory recharging capability. In either case, the implanted RF or rechargeable neuroregulator is connected to two leads, the electrodes of which are laparoscopically implanted onto the anterior and posterior vagal trunks.

**3) Preliminary results**

Patient use of the RF system in a multi-center international clinical trial is underway. Assessment of the rechargeable neuroblocking system is expected to begin soon.

**4) Conclusions/Future directions**

Procedures that are capable of reducing mortality and morbidity while fostering weight loss are highly desirable. The early results of ongoing human studies assessing the safety and efficacy of VBLOC Therapy and the initiation of US clinical trials are highly anticipated. VBLOC Therapy is not available or approved for use in the United States.

## ET011

ENDOLUMINAL FUNDOPERLATION (ELF) BY TRANSORAL DEVICE, Guy-Bernard Cadière MD, Amin Rajan MD, G. Dapri MD, Jacques Himpens MD, Department of Gastrointestinal Surgery, Saint-Pierre University Hospital, Brussels, Belgium1, Unit of Gastroenterology and Endoscopy, Chirec, Brussels, Belgium2

**Background:** The use of the first generation EsophyX device (EndoGastric Solutions Inc., Redmond, WA), for treatment of GERD was evaluated in a prospective Phase 1 clinical trial in patients who were unsatisfied with proton pump inhibitors (PPI) and who were referred for Nissen fundoplication surgery. The ELF procedure was intended to reconstruct the anti-reflux barrier through the creation of a 3-5 cm valve at the GE junction, reduction of hiatal hernia (HH) and restoration of the angle of his.

**Methods:** Inclusion criteria included GERD symptoms >6 months, and PPI dependence. Exclusion criteria were: BMI > 30, irreducible HH > 2 cm, stricture, Barrett's esophagus, ulcer, dysphagia, esophageal motility disorder, or previously failed antireflux procedures. Nineteen patients (7M/12F) were enrolled between June and October 2005 with intent to
<figure><img src="image_197.png" /></figure>

treat, but one patient was not treated due to presence of stricture/stenosis. Among the 18 patients treated, another patient was excluded due to 6 cm HH. Median age of the remaining 17 patients (7M/10F) was 34 years (23-58), median duration of symptoms was 10 years (3-15), and median duration of PPI use was 6 years (2-13). All patients were taking daily PPIs at between 20-40 mg prior to the procedure.

**Results:** Median operative time was 123 minutes (55-254), median number of fasteners placed was 11 (6-14), median length of the ELF valve was 4 cm (3-5), median circumference of the ELF valve was 210 degrees (180-270 degrees), median hospital stay was one day. Adverse events were limited to mild to moderate throat irritation and epigastric pain, which resolved spontaneously. One patient was readmitted for persistent pain assessment and was released from the hospital after three days with no clinical sequelae. No anatomical correlates were found. After 12 months, 82% (14/17) of the patients remained completely off PPIs, 63% (10/16) patients had normal pH (pH <4 for </= 5.3% time measured with the Medtronic BRAVO system), 57% of patients had greater or equal to a 50% improvement in median GERD-HRQL scores (17 to 7), and 76% (13/17) of the patients had HH and all of these were reduced.

**Conclusions:** The results of this Phase 1 trial demonstrate the technical feasibility and safety of the ELF procedure and provide preliminary data on efficacy and longer term durability. Future device and procedural refinements are expected to dramatically reduce procedure time and improve clinical efficacy. A Phase 2 study is underway.

## ET012

### STOMACH RESTRICTION WITH AN EXTRAGASTRIC BALLOON, Michael Gertner MD, Stanford University

The objective of this developmental stage technology is development of a gastric displacement device which resides between the stomach and the abdominal wall. Because the implantation procedure does not involve penetration of the gastric wall and the device does not circumscribe the stomach and apply a high pressure, it is anticipated that this device will ultimately have an improved safety profile over the Lap-Band™. This device is implantable with a modified PEG procedure so that minimal anesthesia will be required. The device was created by dipping a polypropylene mesh into a medical grade silicone and then forming the balloon over a semi-circular mold. Implantation of the balloon was performed by sliding the siliconized mesh over polypropylene sutures. Position and restricting ability were confirmed with a barium swallow. Pressure on the stomach is accomplished with the balloon contacting the anterior portion of the stomach with posterior support behind the stomach from the retroperitoneum.

Over a 5 week period, increasing amounts of saline were added to the balloon reaching a maximum of 100cc at week 4. At the higher balloon volumes, restriction of the stomach was noteable on barium swallow. At 35 days, the balloon was still in firm position. At necropsy, a capsule was noted around the balloon and there was no evidence of erosion of the mesh or the balloon. The device was easily removable after entrance into its capsule.

Ongoing work involves larger animal trials, a longer follow-up period, and miniaturization of the device.

## ET013

### ENDOSCOPIC WATER JET ABLATION OF BARRETT'S ESOPHAGUS, Matthew D Kroh MD, Robert Hall MD, Suthep Udomsuwaengsup MD, Alexander Smith BS, Lisa Yerian MD, Bipan Chand MD, Cleveland Clinic

**Background:** The optimal management of Barrett's esophagus, a precursor to esophageal adenocarcinoma, remains controversial. Current therapy includes surveillance, and ablative and resection techniques of varying safety and efficacy. The purpose of this study is to determine the feasibility of a new catheter-based, endoscopic water jet technique

to ablate Barrett's epithelium.

**Methods:** We have developed a high-pressure flexible catheter that can be passed through the working port of a gastroscope that has micro-drilled holes on one side near the tip. Under foot pedal control and endoscopic vision, a contiguous 4 cm water jet is delivered at pressures adjustable from 100 to 700 psi. After approval from our IRB, tissue segments from esophagectomy specimens were ablated by the catheter without using an endoscope. Using gross appearance and histologic analysis, variable pressures and times were evaluated.

**Results:** A total of 11 ablation sessions were performed, using variable pressures and times: 5 on normal esophagus, 4 on normal stomach, and 2 across the GE junction in the setting of Barrett's. Using ablation pressures of 150-300 psi for 30-60 seconds resulted in selective ablation of mucosa with preservation of the muscularis propria. This was determined by gross inspection at the time of ablation and confirmed by histologic evaluation. There was no embedding of epithelial cells in the muscularis propria. In a single normal esophagus specimen, 400 psi for 120 seconds resulted in gross perforation.

**Conclusion:** Selective ablation of Barrett's esophagus using a catheter-based water jet ablation technique is feasible. This preliminary data using a non-endoscopic technique shows that the epithelium can be removed while preserving the underlying submucosa and muscular layers. Further studies are warranted and will focus on defining more precisely the pressure and duration required for optimal results and the practical application of this technique endoscopically.

## ET014

### A NEW DEVELOPMENT OF THE ENDOSEW™ INTRACORPORAL SUTURING MACHINE: FROM LINEAR TO CIRCULAR ANASTOMOSIS, S Perretta MD, J Leroy MD, B Dallelagne MD, C Moll*, J Marescaux, IRCAD-EITS, University of Strasbourg, France/ * KARL STORZ, Germany

**Background:** Laparoscopic intracorporeal suturing might be challenging and has a steep learning curve. We present a new development of the suturing EndoSew™ system intended to perform intracorporeal end-to-end anastomosis with the objective to shorten suturing time and improve the quality of anastomosis.

**Aim:** to test the new EndoSew™ system to perform end-to-end small bowel anastomosis in a survival animal model.

**Materials:** the EndoSew™ system is composed of two parts: a driving unit, (Unidrive II with EC Motor) connected to the EndoSew™ machine and to a foot pedal that controls the system and, the sewing machine itself which consists of a handle and a shaft. The extracorporeal handle contains the gear box and working mechanism. The intracorporeal shaft has at its tip suturing plate. The EndoSewTM is held in a vertical position through a 15mm trocar and is fixed to the operating table. In order to improve the end-to-end anastomosis performed with the linear EndoSew™ system we designed a special ring of 13 mm diameter, attached to the sewing shaft. When the EndoSew™ system is introduced into the abdomen the ring is clicked in its working position. Both ends of bowel are rolled over the ring and the end-to-end anastomosis can be performed in one uninterrupted sewing.

**Methods:** Three male pigs had general anesthesia. After induction of pneumoperitoneum three working ports were inserted. The 15mm metallic sewing machine port was placed 5 cm away from the camera port using the triangulation principle. A segmental small bowel resection was then carried out followed by an end-to-end anastomosis using the EndoSew™ roll system. The mesenteric defect was closed with the linear EndoSew™ machine.

**Results:** EndoSew™ was used to perform 3 end-to-end small bowel anastomosis in three pigs. All the anastomosis were performed successfully with a mean operative time of 15 min, and no technical problems. There were no complications in the immediate post-operative course. An exploratory
<figure><img src="image_198.png" /></figure>

ry laparoscopy performed one week after the procedure, showed no sign of sepsis, leak or bowel obstruction. At mean follow-up of 10 days all the animals thrived with appropriate weight gain and behavioral pattern.

**Conclusion:** End-to-end anastomosis using the EndoSew™ system is feasible and safe in a porcine model. With the potential to facilitate and expedite advanced suturing technique, our study encourages future developments and further additional application of the EndoSew™ in the field of laparoscopy.

## ET015

### USE OF A NEW ENDOLUMINAL DEVICE IN THE TRANSORAL ENDOSCOPIC SURGICAL PROCEDURE FOR THE TREATMENT OF WEIGHT REGAIN AFTER ROUX-EN-Y GASTRIC BYPASS,

Jacques Himpens MD, Michel Cremer MD, Guy-Bernard Cadiere MD, Dean Mikami MD, 1Sint Blasius Hospital, Dendermonde, Belgium; 2Saint-Pierre University Hospital, Brussels, Belgium, 3Ohio State University, Columbus, Ohio, U.S.A.

**BACKGROUND:** Roux-en-Y gastric bypass procedure (RYGBP) is the most common weight-loss bariatric surgery in the United States. However, 25-30% of patients regain weight after 2 years as a result of dilatation of the gastric pouch and of the gastro enteral anastomosis. The StomaphyX™ system (EndoGastric Solutions, Inc., Redmond, WA) was developed to allow gastric pouch reduction by transoral endoluminal plication using polypropylene fasteners and evaluated for safety and feasibility in revising the gastric pouch.

**METHODS:** Patients who underwent laparoscopic RYGBP and regained weight after 2 years were selected for the study. Ten patients were treated in two sessions (n=5 in Dec 2006, n=5 in Jan 2007) and have been followed for at least 21days.

**RESULTS:** Total median procedure time was 22 min (range 14-90). An average of 5 (4-7) and 9 (8-12) fasteners were deployed. The pouch size was reduced by up to approximately 25% in the first session and 50% in the second. There were no serious complications or deaths. Adverse events were limited to transient drop in hemoglobin and interscapular pain. The first group of patients lost an average of 4 kg (2-7) by day 14 but showed no weight change and no feeling of gastric restriction by day 21, whereas the second group lost an average of 8 kg (6-12) by day 21 and have continued to lose weight. These patients also reported a persistent feeling of gastric restriction and a reduced hunger.

**CONCLUSIONS:** These results support the safety of the new procedure for revision of the post-RYGBP gastric pouch. The procedure was effective in reducing the gastric pouch by up to approximately 50%. Improved clinical results seem to coincide with a higher number of fasteners implanted.

## ET016

### COMORBIDITY AND WEIGHT REDUCTION AFTER ENDOLUMINAL VERTICAL GASTROPLASTY - 31 PATIENTS WITH 3 MONTH FOLLOW-UP,

**INTRODUCTION:** Morbid obesity is a significant global health problem. It is only second to cancer in adult-related mortality and is associated with multiple and various comorbidities. While the surgical methods are effective for weight loss and reduction of some comorbidities, they are associated with significant morbidity and mortality. Endoluminal methods, such as the endoluminal suturing, can provide an alternative to surgical approaches, which may limit adverse complications associated with surgery.

**METHODS:** Thirty-one patients underwent an Endoluminal Vertical Gastroplasty (EVG) procedure using an interrupted suture pattern. The average BMI at the time of procedure was 38.1. Weight measurements and blood chemistry workups were performed at baseline and at 3 months post-procedure. All procedures were performed under general anesthesia.

**RESULTS:** Prior to the procedure, 14 patients suffered from glucose intolerance or type II diabetes, 26 patients suffered from hypertension, and 27 patients suffered from dyslipidemia. Three months after the EVG procedure, only 2 patients suffered from glucose intolerance or type II diabetes (86% reduction), 11 patients suffered from hypertension (58% reduction), and 11 patients suffered from dyslipidemia (59% reduction). At three months, these patients realized an average percent excess weight loss of 46%.

**CONCLUSION:** 1) Endoluminal Vertical Gastroplasty is an effective and safe method for the short-term treatment of morbid obesity, and 2) A significant reduction in comorbidities is realized during short-term follow up. It is mandatory to obtain long-term follow up and a larger number of patients before firm conclusions are obtained.

## ET017

### TRANSVAGINAL CHOLECYSTECTOMY, LAPAROSCOPICALLY ASSISTED, FOR GALLSTONES, A HUMAN CASE,

Marc Bessler MD, Peter Stevens MD, Luca Milone MD, Dennis Fowler MD, Department of Surgery - Columbia University College of Physicians & Surgeons

**BACKGROUND:** NOTES cholecystectomy has so far only been proven to be technically feasible in a large animal model. Many articles have been published regarding abdominal organ removal via the stomach, the rectum or the vagina. After working as a team in the laboratory on a porcine model we obtained IRB approval for performing Trans Vaginal Cholecystectomy (TVC) in human patients.

**SURGICAL TECHNIQUE AND RESULTS:** The patient was positioned in low lithotomy position. One 5mm and two 3mm laparoscopic trocars were placed. A laparoscope was placed at the umbilicus to aid introduction of the gastro-scope transvaginally. A double channel therapeutic gastro-scope was inserted through a flexible, locking overtube (ShapeLock, USGI). After elevating the uterus, with the patient in steep Trendelenberg position, the endoscope was inserted into the vagina. Under direct laparoscopic visualization a needle knife was used to puncture the vaginal wall posterior to the cervix followed by a wire and balloon to allow the endoscope to proceed into the abdomen. From this point on only the endoscopic view was used to accomplish the operation. A laparoscopic grasper was used to retract the gallbladder fundus to the RUQ. An endoscopic hook knife and a grasper biopsy forceps were inserted into the endoscopic channels and the dissection was commenced. The combination of grasping and cutting with the endoscopic instruments and the deflection movements of the tip of the endoscope were used to accomplish the dissection. Dissection was assisted with laparoscopic instruments as needed. Once the dissection was completed, the gallbladder was removed from the abdomen through the incision in the vagina. The colpotomy was closed with absorbable sutures. The gallbladder was 15 cm long, 5cm wide, thickened and hydropic, and contained multiple 1cm stones, one of which was impacted in the neck. Operative time was 3.5 hours. The patient was feeling well after the operation but, this being our first TVC, we elected to observe her overnight and she was discharged on post-op day #1.

**CONCLUSION:** We have demonstrated that hybrid transvaginal cholecystectomy is feasible. Training in the animal lab and the combination of surgical and endoscopic skills was mandatory and important for accomplishing this procedure. The development of new instruments dedicated to NOTES will allow expanded use of this technique.
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**ETP001 Evaluation of the Safety and Efficacy of NiTi Compression Anastomosis Clip (CAC) in an Experimental Colonic Anastomosis Model** Koiana Trencheva, Krista La Perle, Toyooki Sonoda, Sang Lee, Zack Sisko, Jeffrey Milsom, Weill Medical College of Cornell University-New York Presbyterian Hospital NY, USA

**ETP002 Building a Bridge to NOTES: Hybridization of NOTES and Flexible Laparoscopy in the Porcine Model** Raza M Zaidi, MD, Amit Joshi, MD, Eugene Rubach, MD, George DeNoto, MD, Niraj Kaushik, MD, Gary Gecelter, MD, North Shore - LIJ Health System

**ETP003 Nanoparticle Phosphor Intracorporeal Light Generation for "External Beam" Photodynamic Therapy in Murine Lung Cancer Model** Joseph S Friedberg, MD, Joshua E Collins, MS, Ba T Nguyen, BS, Thiru V Lakshman, MD, Melissa J Culligan, RN, Howard Bell, BS, University of Pennsylvania and Sunstones, Inc

**ETP004 REMOVABLE FULL-COVERED SELF EXPANDABLE METALLIC STENT (SEMS) FOR BENIGN INTESTINAL ANASTOMOTIC STRICTURE** Fausto Fiocca, MD, Gianfranco Donatelli, MD, Vincenzo Ceci, MD, Fabrizio Cereatti, Antonio Bruni, MD, Mario Corona, MD, Filippo M Salvatori, MD, Department of Emergency Endoscopic Surgery - University "La Sapienza" - Policlinico Umberto I - Rome, Italy

**ETP005 Image Reversal Algorithms for Robotic Natural Orifice Translumenal Endoscopic Surgery** John Afthinos, MD, Julio Teixeira, MD, James McGinty, MD, Faiz Bhora, MD, Sandhya Balaram, MD, Cliff Connery, MD, Marc Attiyeh, BS, Avinash Burra, BS, Domingo Nunez, MD, Daniel Swistel, MD, George Todd, Scott Belsley, MD, St. Luke's - Roosevelt Hospital Center

**ETP006 Belly-Cam: A hands free, smart laparoscopic imaging system** Timothy W Perez, MD, Robert Johnson, MS, William Radigan, BS, Albuquerque Surgical Consultants

**ETP007 Single Port Surgery and the Dundee Endocone** Stuart I Brown, PhD, Alfred Cuschieri, MD, University of Dundee, UK

**ETP008 Long Term Outcome of Gastric Electric Stimulation for Refractory Gastroparesis** J R Salameh, MD, R S Schmieg, MD, J M Runnels, MD, T L Abell, MD, Departments of Surgery and Medicine, University of Mississippi, Jackson, Mississippi

**iETP009 AN OFFICE BASED SYSTEM FOR ACCESSING IMPLANTED PORTS** James Ellsmere, MD, Daniel B Jones, MD, William Wells, PhD, 1. Department of Surgery, Beth Israel Deaconess Medical Center, Boston MA, 2. Department of Radiology, Brigham and Women's Hospital, Boston MA

**ETP010 The discrimination of expert and novice surgeons based on prefrontal cortical activation during a technical surgical task** Daniel R Leff, BS, Julian J Leong, BS, Louis Atallah, PhD, Thanos Athanasiou, PhD, Peck Hui-Koh, Clare E Elwell, David t Delpy, Guang-Zhong Yang, PhD, Ara Darzi, MD, Imperial College London and University College London

**ETP011 Clinical Application of a Novel Gaseous Airway Reflux Detector in Infants and Children** Chris Landon, MD, Ventura County Medical Center

**ETP012 Natural Orifice Robotic Surgery: da Vinci™ Longo technique description** Adrian LOBONTIU, MD, Daniel RABREAU, MD, Paul-Henri CUGNENC, MD, Claude TAYAR, MD, Daniel LOISANCE, MD, (1)Henri Mondor Hospital - Créteil, Paris XII, France and (2)European Hospital Georges Pompidou - Paris, France

**ETP013 Radiofrequency ablation of liver tumors: a novel needle perfusion technique enhances efficiency** Paolo Abitabile, MD, Christoph A Maurer, MD, Kantonsspital Liestal, Switzerland, Clinic for General, Visceral, Thoracic and Vascular Surgery

**ETP014 Rebound HRD (Hernia Repair Device)** Roderick B Brown, MD, Glacial Ridge Health System, Minnesota Medical Development Inc.

**ETP015 TEM as a portal for NOTES** P M Denk, MD, M H Whiteford, MD, L L Swanstrom, MD, Legacy Health System, Portland, OR

**ETP016 Laparoscopic umbrella system for mesh placement in Ventral hernia** Brij B Agarwal, Nayan Agarwal, Krishna A Agarwal, Manish K Gupta, MS, Sneh Agarwal, MS, Krishan C Mahajan, MS, Sir Ganga Ram Hospital, Lady Hardinge Medical College & DPS, RK Puram, India

**ETP017 Natural Orifice Translumenal Surgery: long term survival study after closure of the gastrotomy using a cardiac septal occluder in a porcine model** Silvana Perretta, MD, Bernard Dallemagne, MD, Stefano Sereno, MD, Antonello Forgione, MD, Dimitri Coumaros, MD, Christof Boosfeld, Jacques Marescaux, MD, IRCAD-EITS. University of Strasbourg. France/ * DRABO / Occlutech, Germany

**ETP018 The effect of a compression mechanism on energy based vessel sealing** Marc Singer MD, Linda S Oleson, University of Illinois, Chicago, SurgRx, Inc.

**ETP019 Preliminary Report of a Novel Gastric Sensing and Electrical Stimulation Device to Treat Obese Subjects with T2DM** John Pilcher, MD, Mark Kipnes, MD, Edy Soffer, MD, Jeffrey Conklin, MD, Scott Cunneen, MD, Diabetes and Glandular Disease Research Associates, Inc. San Antonio, Texas and Cedars Sinai Medical Center, Los Angeles, California

**ETP020 Endoluminal Approaches to Bariatric Surgery: A New Application of the Modified NDO Plicator** Carol A McCloskey, MD, Anita P Courcoulas, MD, Amos Cruz, George Eid, MD, University of Pittsburgh Medical Center and the VA Health Care System

**ETP021 DEVELOPING AN ULTRASONIC PROBE FOR TUMOR ABLATION IN LIVER: Experimental Results with morphological analysis of the ultrasonic lesions.** Belhassen Seket, MD, Cyril Lafon, PhD, Rares Salomir, PhD, François Mithieux, MD, Jean-Yves Chapelon, PhD, Michel Rivoire, MD, Dominique Cathignol, PhD, Insitut National de la Santé et de la Recherche Médicale (INSERM) unité 556, Université Claude Bernard - Iyon 1 and Centre Léon Bérard (Institut de Chirurgie Expérimentale), Lyon, France.

**ETP022 Development of Hybrid Surgical Simulation Device** Cronwel N Irias, Daniel A Hashimoto, Daniel M Jones, MD, Beth Israel Deaconess Medical Center

**ETP023 Pilot Study on the Effects of Gastric Electrical Stimulation (TANTALUS™) on Glycemic Control in Morbidly Obese Patients with Type 2 Diabetes (T2DM)** Arthur Bohdjalian, MD, Bernhard Ludvik, MD, Rudolph Weiner, MD, Christoph Rosak, MD, Gerhard Prager, MD, Medical University of Vienna, Dept. of Surgery and Internal Medicine III; Krankenhaus Sachsenhausen Frankfurt, Dept. of Surgery and Internal Medicine

**ETP024 USEFULNESS OF ELECTRICAL STABILIZATION OF LAPAROSCOPIC IMAGE AND DEPTH PERCEPTION BY MOVEMENT PARALLAX IN LAPAROSCOPIC SURGERY** Tatsuo Igarashi, MD, Yukio Naya, MD, Harufumi Makino, MD, Hideki Hayashi, MD, Research Center for Frontier Medical Engineering, Chiba University

**ETP025 Transcorporeal Magnetic Retraction of Luminal Viscera** Stephen Van Lue, DVM, DACVS, Anne Palsgaard-Van Lue, DVM, University of Copenhagen, Faculty of Life Sciences, Copenhagen, Denmark

**ETP026 Transbronchial Evaluation of Mediastinal Lymph Nodes: A Single Institution's Early Experience with Endobronchial Ultrasound** Shawn S Groth, MD, Bryan A Whitson, MD, Michael A Maddaus, MD, Rafael S Andrade, MD, University of Minnesota Department of Surgery
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SAGES EMERGING TECHNOLOGY POSTER LISTING

**ETP027 Real-Time Imaging of the Common Bile Duct using Infrared Technology in a Porcine Model** Ben R McHone, MD, Alexander Gorbach, PhD, Jack Liu, BA, Mehrdad Alemozaffar, BA, Nadeem Dhanani, MD, Fred Gage, PhD, Peter Pinto, MD, Eric Elster, MD, National Cancer Institute, National Institute of Biomedical Imaging, Naval Medical Research Center

**ETP028 Design and instrumentation of new devices for performing appendectomy at colonoscopy.** Gerd Silberhumer, MD, Tudor Birsan, MD, Ewald Unger, MD, Winfried Mayr, MD, Johannes Zacherl, MD, Gerhard Prager, MD, Christoph Gasche, MD, Medical University Vienna, Department of Surgery, Department of Gastroenterology and Hepatology

**ETP029 Endoscopic Esophageal Mucosectomy Using a Multipurpose Therapeutic Hood (TxHood)** Tatsuyuki Kawano, MD, Shigeo Haruki, MD, Tokyo Medical and Dental University Hospital

**IETP030 Radiofrequency Ablation for Lung Tumors** Ghulam Abbas, MD, Arjun Pennathur, MD, Rodney J Landreneau, MD, James D Luketich, MD, University of Pittsburgh Medical Center

**ETP031 The Establishment of a Large Animal Survival Model of Laparoscopic Roux-en-Y Gastric Bypass to Study Subsequent Gastrojejunostomy Reduction Using the RESTORE™ Suturing System** David B Lautz, MD, Cesar E Escareno, MD, Ikram V Kureshi, MD, Arthur Nedder, Ali Tavakkolizadeh, MD, Kerri A Clancy, RN, Ajay Maker, MD, Michele Ryan, MS, Christopher C Thompson, MD, Brigham and Women's Hospital, Harvard Medial School, Boston MA

**ETP032 LTS3e Augmented Reality Laparoscopic Simulator** Andrée Sansregret, MD, Paul Yarin, MS, David Hananel, BS, Harrith M Hasson, MD, Univ. of Montreal, Blackdust Design, Medical Education Technologies, Inc., Univ. of New Mexico

**ETP033 Dx pH measurement System. A Sensitive Radiotelemetry Device for Detecting Liquid and Aerosolized Supraesophageal Gastric Reflux (SEGR)** Harry S Miller, MD, Tomas Garibaldi-Hardy, H.G.R.#20 of The Instituto Mexicano del Seguro Social & Restech Corp. USA

**ETP034 Endo-Laparoscopic Intra gastric Tumor Excision (ELITE) - An Emerging Concept of Synchronized Laparoscopy-Endoscopy Approach** Simon K Wong, MD, Michael Li, MD, Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong

**ETP035 Microwave Ablation of Liver Tissue: The Future of Hepatic Tumor Ablation** John P Cullen, MD, David W Easter, MD, Sonia Ramamoorthy, MD, Brian Datnow, MD, Santiago Horgan, MD, Mark A Talamini, MD, Yoav Mintz, MD, University of California at San Diego

**ETP036 Evaluation of the Use of a New Impedance Controlled Bipolar Device with Monopolar Capability** Thomas M Schmelzer, MD, William W Hope, MD, William L Newcomb, MD, Keith S Gersin, MD, David A Iannitti, MD, B. Todd Heniford, MD, Carolinas Medical Center

**ETP037 Irreversible Electroporation for the Ablation of Malignant HCC Tumors** Brett Sheppard, MD, Douglas Faigel, MD, Gary Long, PhD, Dave Plescia, MS, Christie Cunningham, BS, Phil Long, PhD, NOTES Development Group, Oregon Health Sciences University (OHSU), Portland OR Ethicon Endo-Surgery Cincinnati OH, Vet Path Services, Inc Mason, OH

**ETP038 A COMPARISON OF BURST PRESSURES OF GASTROJEJUNAL ANASTOMOSES WITH OR WITHOUT BUTTRESSING IN A PORCINE MODEL** William W Hope, MD, Marc Zerey, MD, B. Lauren Paton, MD, William L Newcomb, MD, Albert Y Chen, MD, Jessica J Heath, BS, Richard D Peindl, PhD, Amy E Lincourt, PhD, Timothy S Kuwada, MD, B. Todd Heniford, MD, Keith S Gersin, MD, Carolinas Medical Center

**ETP039 Early Clinical Results Using GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement (CBSG) For Circular Staplers** Wesley B Jones, MD, Katherine M Myers, Eric S Bour, MD, Greenville Hospital System University Medical Center, Department of Surgery, Greenville, SC, USA

**ETP040 Repair of Inguinal Hernia in Developing Countries** Tehemton E Udwadia, Breach Candy and Hinduja Hospitals, Mumbai.

**ETP041 Articulating Needle Holder Design** Tim Frank, PhD, Stuart Brown, PhD, Alfred Cuschieri, Department of Surgery and Molecular Oncology, University of Dundee, UK and Cuschieri Skills Centre, University of Dundee, UK

**ETP042 New 2 mm instruments not requiring trocars for Minimally invasive surgery** Ashutosh Kaul, MD, Ravi Kumar, MD, New York Medical College

**ETP043 Efficacy of Fully Covered Self-Expanding Nitinol Stents in the Treatment of Dysphagia for Patients with Refractory Anastomotic Stricture After Esophagectomy** Rajnish Mishra, MD, Paul Yeaton, MD, Michel Kahaleh, MD, Vanessa Shami, MD, University of Virginia Health System

**ETP044 A Direct Drive Endoscopic System for Complex Endoluminal and NOTES Applications** C C Thompson, RI Rothstein, NJ Soper, M Ryou, D G Fong, R D Pai, PJ Smith, B D Weitzner, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Dartmouth Hitchcock Medical Center, Dartmouth Medical School, Hanover, NH, USA; Northwestern University, Chicago, IL, USA; Boston Scientific, Marlborough, MA, USA

**ETP045 Building virtual reality haptic interfaces: The contributions of operative experience** Allan Okrainec, MD, Heather Carnahan, PhD, Liya Ni, PhD, David Wang, PhD, Adam Dubrowski, PhD, University of Toronto and University of Waterloo

**ETP046 Effectiveness of Virtual Instructor Feedback on Novice Learner Performance Using the GI Mentor II Gastrointestinal Endoscopy Simulator** James G Bittner IV, MD, Adeline M Deladisma, MD, Michael A Edwards, MD, Edward J Kruse, DO, John D Mellinger, MD, Mary Anne Park, MSc, Bruce V MacFadyen Jr., MD, D. Scott Lind, MD, Department of Surgery, Medical College of Georgia School of Medicine

**ETP047 Decision Aids in Laparoscopic Cholecystectomy** Dawit Worku Gebrehiwot, MD, St. Bartholomew's and The London School of Medicine and Dentistry

**ETP048 2-dimensional gel plasma proteomics: A tool for the assessment of the plasma protein response to illness and surgical intervention** John M Bennett, BA, Abigail C Polley, PhD, Mike Rhodes, MD, Ian T Johnson, PhD, Fran Mulholland, PhD, Institute of Food Research

**ETP049 TROCAR FOR LAPAROSCOPIC PLACEMENT OF CATHETER FOR PERITONEAL DIALYSIS** Zoran Cala, PhD, Ivo Soldo, PhD, Irena Senecic-Cala, MSc, Visnja Nesek-Adam, MSc, Univ Dpt of Surgery GH Sveti Duh, Univ Dpt of Pediatrics CH Rebro, Zagreb, Croatia

**ETP050 THORACOSCOPIC AND MINI-LUMBAR VERTEBRAL BODY STAPLING USING SHAPE MEMORY ALLOY (NITINOL) IN THE TREATMENT FOR SCOLIOSIS IN CHILDREN** Harsh Grewal, MD, Randal R Betz, Linda P'Andrea, Section of Pediatric Surgery, Temple University Children's Medical Center and Orthopedic Surgery, Shriner's Hospitals for Children, Philadelphia

**ETP051 A NOVEL DEVICE FOR DEFOGGING, HEATING, WHITE-BALANCING, PROTECTING AND CLEANING THE LAPAROSCOPE** Sandy Heck, MD, Alexander Gomez, Brian Jacob, MD, Alfons Pomp, MD, Weill Cornell Medical College, New Wave Surgical Corp.
SAGES EMERGING TECHNOLOGY POSTER LISTING

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**ETP052 THE LAPAROSCOPIC VASCULAR TRANSILLUMINATOR: EFFICACY OF A BLOOD VESSEL IDENTIFICATION DEVICE USING INFRARED EMISSION DIODE Kozo**
Konishi, MD, Kazuo Tanoue, MD, Satoshi leiri, MD, Shohei Yamagchi, MD, Etsuko Kobayashi, MD, Ichiro Sakuma, MD, Takeyoshi Dohi, MD, Makoto Hashizume, MD, 1.Graduate School of Medicine, Kyushu University; 2. Graduate School of Information Science and Technology Medicine, The University of Tokyo

**ETP053 Effective Appetite Management by Proximal Gastric Electric Stimulation B. A Zikria, MD, Leaque**
Ahmad, MD, Joseph F Zikria, BA, M Al-Sawwaf, MD, Arthur Cooper, MD, Harlem Hospital Medical Center, Columbia University, New York

**ETP054 Robotic telepresence offers an alternative paradigm for post-residency surgical education Alex Gandsas, MD,**
John S Koppman, MD, Christina Li, MD, Stuart Shindel, MD, Michael Schweitzer, MD, Sergio Cantarelli, MD, Gabriel Egidi, MD, Sinai Hospital of Baltimore and Johns Hopkins Bayview Medical Center

**ETP055 Comparison of task performance between articulating and conventional laparoscopic instruments Prakash**
Gatta, MD, Peter M Denk, MD, Bin Zheng, PhD, Lee L Swanstrom, MD, Legacy Health System

**ETP056 Minimally traumatic suturing device for laparoscopic ventral hernia repair (LVHR) Brij B Agarwal, MS,**
Krishna A Agarwal, Nayan Agarwal, Manish K Gupta, MS, Sneh Agarwal, MS, Krishan C Mahajan, MS, Sir Ganga Ram Hospital, Lady Hardinge Medical College & DPS, RK Puram, India

**ETP057 Objective measurement of FLS Precision Cutting**
Task Derek Young, Fiona Slevin, Derek Cassidy, Donncha Ryan, Haptica Inc

**ETP058 The novel use of self-expanding, covered, plastic esophageal stents (SEPS) in the management of benign colorectal anastomotic strictures**
William J Peche, MD, Kirsten B Wilkins, MD, Kelly M Tyler, MD, Theodore E Eisenstat, MD, Gregory C Oliver, MD, Joseph R Notaro, MD, Daniel Simon*, MD, Bertram T Chinn, MD, Department of Colon and Rectal Surgery, UMDNJ-Robert Wood Johnson University Hospital, New Brunswick, NJ and *Department of Radiology, Solaris Health Systems, Edison, NJ

**ETP059 Surgical Staplers With Magnetically Secured Components**
Stephen Van Lue, DVM, DACVS, University of Copenhagen, Faculty of Life Sciences, Copenhagen, Denmark

**ETP060 Magnetic Optical Suturing**
Stephen Van Lue, DVM, DACVS, University of Copenhagen, Faculty of Life Sciences, Copenhagen, Denmark

**ETP061 Support where it's needed: Smart Arm Stuart I**
Brown, PhD, Ian Rutherford, University of Dundee, UK

**ETP062 New curriculum for acquiring "Surgical Skills" using Virtual Reality Surgical Simulation. S Ivanova, MD,**
N Iqbal, T Albrani, B Patel, Academic Department of Upper GI Surgery, Barts and The Royal London School of Medicine and Dentistry. Queen Mary, University of London. Institute of Cancer, Old Anatomy Building, Charterhouse Square, London, United Kingdom, EC1M 6BQ.

**ETP063 Development of Simulation for Practicing Laparoscopic Hernia Repairs and Gastric Bypass**
Yael Friedman, PhD, Simbionix Corp.

**ETP064 Antimicrobial nanoparticle surface functionalization to prevent biofilm formation on medical devices**
Roger Massengale, Bruce Gibbins, PhD, Alan Dine, BS, I-Flow Corporation, Acrymed Inc.

**ETP065 RADIOFREQUENCY ASSISTED LAPAROSCOPIC LIVER RESECTION: INITIAL EXPERIENCE WITH THE LAPAROSCOPIC HABIB DEVICE**
Alejandro Mejia, MD, Stephen Cheng, MD, THE LIVER INSTITUTE - METHODIST DALLAS

**ETP066 Temporary Stent Placement After Colorectal Anastomosis Using Polyflex system: An Animal Model**
Zurab Tsereteli, MD, Tim M Geiger, MD, Christopher Edwards, MD, Sharon Backman, MD, Nitin Rangnekar, MD, Brent Miedema, MD, Klaus Thaler, MD, University of Missouri-Columbia, Columbia, MO, Department of General Surgery

**ETP067 Preliminary Results Utilizing a Bioabsorbable Omega-3 Fatty Acid Coated Lightweight Polypropylene Mesh for Open and Laparoscopic Ventral and Inguinal Hernia Repair**
Richard A Pierce, MD, Margaret M Frisella, RN, Laura M Todt, BS, Brent D Matthews, MD, Washington University School of Medicine and Institute for Minimally Invasive Surgery, Saint Louis, Missouri, USA

**ETP068 Twin Input Insufflator**
Krishna A Agarwal, Brij B Agarwal, MS, Nayan Agarwal, Sneh Agarwal, MS, Krishan C Mahajan, MS, Sir Ganga Ram Hospital, Lady Harding Medical College & DPS-RK Puram, India

**ETP069 Transgastric Endoscopic Diagnostic Peritoneoscopy in Humans**
Jeffrey W Hazey, MD, Scott Melvin, MD, Vimal K Narula, MD, Peter Muscarella, MD, Christopher Ellison, MD, The Ohio State University

**ETP070 GUIDELINE FOR CHOLECYSTECTOMY BY NOTES,**
Kiyoshi Hashiba PhD, Sergio Roll PhD, Marco A D'Assuncao MD, Pablo R Siqueira MD, Hospital Sirio Libanes, Gastrointestinal Endoscopy Unit, Sao Paulo, Brazil

**ETP071 ANALYSIS OF PARAMEDIAN ABDOMINAL WALL DEFECTS FOLLOWING INTENTIONAL ACCESS CANNULA MANIPULATION IN SWINE, Rich Schiretz MS,**
Steve Izzo BS, Greg Okoniewski BS, Russell Heinrich PhD, United States Surgical
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# SAGES EMERGING TECHNOLOGY POSTER ABSTRACTS

## ETP001

### EVALUATION OF THE SAFETY AND EFFICACY OF NITI COMPRESSION ANASTOMOSIS CLIP (CAC) IN AN EXPERIMENTAL COLONIC ANASTOMOSIS MODEL, Koiana

Trencheva, Krista La Perle, Toyooki Sonoda, Sang Lee, Zack Sisko, Jeffrey Milsom, Weill Medical College of Cornell University-New York Presbyterian Hospital NY, USA

**BACKGROUND:** The compression anastomotic clip (CAC), NiTi Medical Technologies, Israel, is a new mechanical device that uses temperature-dependent memory-shape nickel-titanium to produce a sutureless bowel anastomosis. The aim of this study was to evaluate the usefulness, safety, and efficacy of the NiTi CAC in colonic anastomoses.

**METHODS:** 14 female Yorkshire pigs (30-35 kg) underwent large bowel resection (LBR) with anastomosis in 3 groups: Group1 (Gp1) CAC version 1; Group 2 (Gp2) CAC version 2 and Group 3 (Gp3) CAC version 3 with 6, 2 and 6 animals respectively. The 3 experiments done consecutively involved improvement of the CAC and diet modification. LBR was done using a linear stapler and side-to-side anastomosis using the NiTi CAC. Post-op animals were observed for: vital signs, Gl recovery, complications, and clip expulsion. Necropsies were done 12-13 days post surgery. Anastomotic sites were: leak tested, bursting pressures measured and evaluated histologically.

**RESULTS:** No animals in Gp3 had an abdominal distention vs. 100% (6) in Gp1 (p<0.001). One animal from Gp1 had bowel obstruction and peritonitis and was euthanized. Bursting pressure was > 250-300 mmHg in 92.3% (12) of the animals. Tissue within the clip was necrotic but failed to slough in 83.3% (10). NiTi anastomosis exhibited excellent apposition of the bowel wall in slight inversion, moderate amount of highly vascular granulation tissue, mature collagen and minimal to mild inflammation (See Image). The everted staple line site exhibited junctional invagination and significant architectural disruption resulting in delayed healing and had mild to moderate inflammation and fibrosis.

**CONCLUSION:** The CAC histology revealed less inflammation and better healing at the NiTi anastomotic sites compared to staple lines. CAC (Version 3) appears to be useful and safe for colonic anastomoses, although partially remaining necrotic tissue within the clip is still a concern for post-op bowel obstruction.

<figure><img src="image_203.png" /></figure>

## ETP002

### BUILDING A BRIDGE TO NOTES: HYBRIDIZATION OF NOTES AND FLEXIBLE LAPAROSCOPY IN THE PORCINE

**MODEL, Raza M Zaidi MD, Amit Joshi MD, Eugene Rubach MD, George DeNoto MD, Niraj Kaushik MD, Gary Gecelter MD, North Shore - LIJ Health System**

**INTRODUCTION:** Park described Natural Orifice Translumenal Endoscopic Surgery (NOTES) transgastric cholecystectomy in the porcine model. Pai noted that transgastric cholecystectomy was limited by retroflexed views making en face visualization and dissection difficult. Alternatively, they approached the gallbladder though a colotomy. Both studies described the need for effective luminal closure. We propose a method utilizing the techniques of NOTES procedures via a transumbilical access port. A NOTES hybridization technique with flexible laparoscopy may allow easier spatial orientation while avoiding complications from the visceral puncture. It may also be an intermediary between conventional laparoscopic and completely translumenal procedures that still maintains cosmesis and minimizes pain. This is a unique approach to a novel surgical paradigm that may ultimately facilitate the widespread acceptance of this new technology.

**HYPOTHESIS:** This project aims to prove that a NOTES hybridization technique is feasible in an animal model with

greater technical ease using current endoscopic technology.

**METHODS:** Yorkshire pigs are used in an approved animal laboratory. Under general anesthesia, pneumoperitoneum is established to 15 mmHg. A single 15-mm transumbilical laparoscopic port is inserted. A double channel endoscope is then inserted visualizing the peritoneal cavity. The gallbladder is identified and held with a grasping forceps, retracting it away from the gallbladder fossa. Cystic artery and vein are visualized using needle knife, biopsy forceps, hook knife and snare cautery. The cystic artery and duct are then endoclipped and transected. The gallbladder specimen is then withdrawn via the umbilical access port. The gallbladder fossa is examined for hemostasis and absence of biliary spillage. The procedure is then terminated and necropsy is performed to confirm correct placement of endoclips, maintenance of hemostasis and evaluate for unintended organ injury. Data is collected involving procedure time, estimated blood loss, visualization of peritoneal organs, and technical difficulty.

**CONCLUSIONS:** Using NOTES techniques, we propose that the complications related to the visceral organ puncture can be avoided using a transabdominal approach. This technique avoids the need for retroflexion of the endoscope, keeping en face orientation, maintaining the benefits of surgery through minimal incisions, while, avoiding a major technique related complication.

## ETP003

### NANOPARTICLE PHOSPHOR INTRACORPOREAL LIGHT GENERATION FOR "EXTERNAL BEAM" PHOTODYNAMIC THERAPY IN MURINE LUNG CANCER MODEL, Joseph S

Friedberg MD, Joshua E Collins MS, Ba T Nguyen BS, Thiru V Lakshman MD, Melissa J Culligan RN, Howard Bell BS, University of Pennsylvania and Sunstones, Inc

Objective of the technology: Photodynamic therapy, PDT, is an effective cancer treatment that requires visible light to activate nontoxic photosensitizing compounds, PS. Because visible light only penetrates several mm into tissue, applications of PDT are limited to superficial tumors that are easily visualized and illuminated. Infrared light, IR has much greater tissue penetration, but does not activate PS. The ability to use IR for PDT could greatly expand the applications of PDT. Rare earth phosphors are inert lanthanide compounds that can capture IR and generate visible light. The objective of these experiments was to see if it was possible to use deep penetrating IR to generate intracorporeal visible light and if that light would be sufficient for PDT.

Methods: Murine LKR13 lung cancer cells were injected into the flanks of SCID mice. Treatment groups included: controls, IR plus phosphors, IR plus phosphors plus PS. PS was Photofrin (25 micrograms/ml), Phosphor was 200nm Ertrium Gadolinium Oxysulfide activated with Erbium and Ytterbium (50mg/ml), Light was 980nm IR (110 J/cm2).

Results: Illumination with IR and phosphors resulted in minimal delay in growth compared to controls, while addition of the PS resulted in PDT induced killing. Mean tumor volumes at 14 days for controls, IR/phosphors and IR/phosphors/PS were: 140, 110 and 10 mm3, respectively.

Conclusions/Future directions: Nanoparticle phosphors can capture deep penetrating IR, which then upconverts to visible light sufficient to effect PDT. These experiments are the first demonstration of the feasibility of this concept. This combination of technologies has potential to greatly expand the applications of PDT and allow minimally invasive treatments of cancers, with PDT, at sites that are currently inaccessible or require major surgical procedures to access for visible light delivery. In addition, the combination of this technology with other novel light delivery strategies, such as luminal refractive index modification (Friedberg, et al JTCVS, 2003), has potential as a minimally invasive treatment of entire cavities for diseases such as pleural or peritoneal carcinomatosis.
## ETP004

**REMOVABLE FULL-COVERED SELF EXPANDABLE METAL-LIC STENT (SEMS) FOR BENIGN INTESTINAL ANASTOMOTIC STRICTURE**, Fausto Fiocca MD, Gianfranco Donatelli MD, Vincenzo Ceci MD, Fabrizio Cereatti, Antonio Bruni MD, Mario Corona MD, Filippo M Salvatori MD, Department of Emergency Endoscopic Surgery - University "La Sapienza" - Policlinico Umberto I - Rome, Italy

New SEMS Niti-S Stent Taewoong Medical Co-Ltd, distributed by Deltamed Italy, full covered and that can be removed, are now available: a nylon stich at both margin of the prosthesis is placed. Endoscopically the stich can be pulled with a foreign body forcep: the prosthesis closes itself and it can slip along the bowel. Up to now SEMS were only for use in malignant intestinal strictures as they cannot be removed. The most frequent complications after digestive surgery are leaks and stenosis of the sutured bowel, occurring with a frequency of 11-13%. Strictures are commonly treated with conservative treatments such as repeated balloon dilatations or endoscopic incision but some times a new surgical treatment is needed. To maintain the patency of the stricture the use of these brand new removable SEMS should be proposed. Patients with colo-rectal anastomotic closure were successfully treated with SEMS, avoiding surgery, achieving the complete recovery of the patients.

**PATIENTS AND METHODS:** 31 patients with benign colo-rectal anastomotic strictures were treated with balloon dilatation along a guide wire placed with endoscopic and fluoroscopic control and a removable SEMS, 22 mm in diameter with distal and proximal enlargement 28 mm to avoid dislocation, was positioned. The procedures were carried out with a conscious sedation and a prophylactic antibiotic therapy. After 1-3 months the prosthesis was endoscopically removed and the patients considered for follow-up at 3-6-12 months to evaluate bowel patency.

**RESULTS:** 3 patients lost their prosthesis through the anus after 20 days. At clinical and endoscopic follow-up 28 patients showed good patency of the colo-rectal anastomosis. 3 patients had a stricture recurrence that required two sessions of balloon dilatation combined with argon-plasma coagulation of the scar.

**CONCLUSION.** The placement of SEMS in order to maintain an adequate lumen and to avoid any possible leak of an anastomotic stricture in colo-rectal surgery has demonstrated to be the gold standard. The use of SEMS seems valid also in term of cost benefits as it is cheaper than repeated endoscopic treatments or a new surgical approach.

## ETP005

**IMAGE REVERSAL ALGORITHMS FOR ROBOTIC NATURAL ORIFICE TRANSLUMENAL ENDOSCOPIC SURGERY**, John Afthinos MD, Julio Teixeira MD, James McGinty MD, Faiz Bhora MD, Sandhya Balaram MD, Cliff Connery MD, Marc Attiyeh BS, Avinash Burra BS, Domingo Nunez MD, Daniel Swistel MD, George Todd, Scott Belsley MD, St. Luke's - Roosevelt Hospital Center

**Objective:** Image reversal in Natural Orifice Translumenal Endoscopic Surgery (NOTES) is underestimated in procedures attempted with laparoscopic instruments that only afford four degrees of freedom. Robotic NOTES that applies a third-party endoscope with the robotic instruments of the Da Vinci System (Intuitive Surgical) that have seven degrees of freedom highlights problems of mirrored views in each spatial dimension. Clinical algorithms to orient the operative surgeon with the endoscopist during complex traditional or robotic NOTES procedures are required.

**Description:** The video image from a flexible gastroscope (Olympus) was spliced through an image reverser (Colorado Video) into the visual field of the operative console of the Da Vinci Robot. The alterations in perceived motion in both the vertical and horizontal axes when looking directly at the trocars as well as in flexed view were recorded first in a lab model and then using two 50 kg pigs where a Robotic NOTES plication with transgastric instrumentation was attempted at the esophageal hiatus.

**Results:** Image reversal follows a reproducible algorithm depending on initial approach, gastroscope rotation and flexion that is elucidated by recording initial movement patterns and orientation of the transgastric trocars. Although four approaches are technically possible, only two allow correspondence of scope position with both horizontal and vertical movements at the esophageal hiatus- 0 degree gastroscope rotation with retroflexion and the use of the video reverser, and 180 degree gastroscope rotation with anteflexion both approached along the greater curvature. Although the later technique does not require an image reverser for flexed image correspondence, it is much more technically difficult for the endoscopist.

**Conclusion:** Complex NOTES instrumentation that requires both direct views and flexed visualization through an endoscope is greatly facilitated with the use of a video reverser. Although clinical orientation is facilitated by noting patterns of vertical and horizontal image reversal, automating this mathematical algorithm represents an area of essential technological development.

## ETP006

**BELLY-CAM: A HANDS FREE, SMART LAPAROSCOPIC IMAGING SYSTEM**, Timothy W Perez MD, Robert Johnson MS, William Radigan BS, Albuquerque Surgical Consultants

**Objective:** In laparoscopic surgery the ability of the surgeon to see is entirely dependent on the skill of the person steering the laparoscope. Current hand-directed rigid laparoscopes suffer from several drawbacks:

- Constant manual adjustment to maintain an optimal view of the surgical field.

- Lack of a separate visual perspective for the assistant

- Rotation of the image off the horizontal

The Belly-Cam laparoscopic imaging system is designed to alleviate these shortcomings by departing from the laparoscope/trocar paradigm. The objective of Belly-Cam is to provide a hands free, optimally positioned view of the operative field for laparoscopic surgeons. Another goal is to engage the first assistant by providing a separate larger perspective image. By achieving these objectives, the Belly-Cam would allow the surgical team to focus on operating and not constantly troubleshooting the camera image.

**Description of the technology and method of its use or application:** Belly-Cam is intended for use within the abdominal cavity. The camera is mounted on a mechanized apparatus that provides horizontal and vertical movement of the lens. Belly-Cam uses a CMOS imaging chip; technology which allows for panning and zooming operations to be performed on the chip. Tracking the surgeon's instruments is possible without manipulating the camera. Movements outside the range of the chip would be tracked by mechanical movement of the camera. The image would be centered based on cues from the dominant hand instrument. Thus, Belly-Cam would provide a hands free, self-adjusting image of the procedure.

Another feature of the CMOS camera is the ability to provide a separate, wide angle image that could be sent to a different monitor. This would provide the assistant with a view of their instrument movements typically outside the surgeon's sight.

**Preliminary Results and Future Directions:** A prototype of the Belly-Cam is under development. Key features, such as "on the chip" panning and zooming, have been demonstrated. Software to control tracking of the instruments and control the camera is under development. The Belly-Cam project team will develop a production model and conduct cadaver testing. An educational/collaborative effort is planned to garner feedback and support for this significant advancement in laparoscopic surgery.

## ETP007

**SINGLE PORT SURGERY AND THE DUNDEE ENDOCONE**, Stuart I Brown PhD, Alfred Cuschieri MD, University of Dundee, UK

**Objective:** The development of modern imaging technologies is resulting in the detection of early gastrointestinal lesions still confined to the mucosa and hence amenable to
SAGES EMERGING TECHNOLOGY POSTER ABSTRACTS

local excision. Prior attempts at laparoscopic endoluminal surgery for such procedures have employed multiple entry ports into the distended (gas inflated) viscus such as the stomach. The endoluminal surgical approach is facilitated by employing a single multi function operating port.

**Description of the technology:** The Endocone system was developed specifically for this application and is based on a conical frustrum with an atraumatic external thread. Mounted within this base unit is a second frustrum containing vision and illumination, ports for 3mm instruments and an insufflation channel. The geometry of the cone has been specifically developed to (a) provide the optimal viewing and manipulation angles; (b) maximise the instrument range of motion; (c) minimise the size of the entry wound. The device is used by firstly entering the abdomen through a laparoscopic approach and mobilising the stomach. The laparoscopic equipment is removed and one of the port sites incisions enlarged to about 20mm length. The mobilised stomach is then externalised through this incision and sutured temporarily to the external abdominal wall, following which a 20mm gastrotomy is made. The base cone is screwed into this gastrotomy and the remaining instrumentation assembled. The endoluminal procedure can then proceed. On completion, the instrumentation is removed and the gastrotomy closed before release of the stomach from the abdominal parietes.

**Preliminary results:** The system has been employed in a porcine model. Accessing the GI tract, mobilising the stomach and setting up the Endocone can be achieved in ten to fifteen minutes. Thereafter, the system was used without difficulty to dissect and remove segments of gastric mucosa. Care must be taken to ensure that the gastrotomy is made in the correct place: ideally opposite the lesion, so that minimal retraction of the tissue is required thereafter.

**Conclusions/Future directions:** Hitherto the Endocone has only been available in prototype form. Industrialisation of the device is now proceeding and further acute animal trials are anticipated to confirm efficacy and safety before clinical use. Intellectual property in the design has been secured by patent application.

### ETP008

### LONG TERM OUTCOME OF GASTRIC ELECTRIC STIMULATION FOR REFRACORY GASTROPARESIS, J R Salameh

MD,R S Schmieg MD,J M Runnels MD,T L Abell MD, Departments of Surgery and Medicine, University of Mississippi, Jackson, Mississippi

**OBJECTIVE OF THE TECHNOLOGY:** Gastric Electrical Stimulation (GES) is used to treat medically refractory gastroparesis and received FDA Humanitarian Use Device approval in 2000. We examined the overall long-term outcomes with GES by underlying diagnosis.

**DESCRIPTION AND METHOD OF USE:** GES uses a battery powered neurostimulator, implantable using laparoscopy or laparotomy, and connected to the gastric antrum with two stimulating electrodes inserted into the muscularis propria 1 cm apart and 10 cm proximal to the pylorus. Recently, temporary endoscopic GES has been used to assess response to stimulation prior to surgically implanting a permanent device. 388 consecutive patients (311 females and 77 males, mean age of 42 years) were consented for GES: 104 patients were implanted with temporary alone, 111 with permanent alone and 140 with temporary followed by permanent GES. 33 consented patients were never implanted but were included in the intention to treat analysis. Average follow-up was 50 months (range: 6 months to 10 years).

**PRELIMINARY RESULTS:** Patients were assessed by IDIOMS (a HRQOL measure) and symptom scores (nausea score, vomiting score and total symptom score or TSS) at baseline and at the latest available follow-up. Percent change in HRQOL and symptoms are reported in the table below.

<table><thead><tr><th></th><th>ALL</th><th>IDIOPATHIC</th><th>DIABETIC</th><th>POST-SURGICAL</th></tr></thead><tbody><tr><td>N</td><td>388</td><td>227</td><td>104</td><td>57</td></tr><tr><td>Baseline HRQOL (max 30)</td><td>16.3</td><td>15.4</td><td>18.8</td><td>15.6</td></tr><tr><td>% improvement in HRQOL</td><td>35.5%</td><td>33.9%</td><td>36.6%</td><td>40.0%</td></tr><tr><td>% improvement in Nausea</td><td>41.7%</td><td>37.6%</td><td>45.2%</td><td>51.3%</td></tr><tr><td>% improvement in Vomiting</td><td>50.7%</td><td>43.1%</td><td>55.6%</td><td>72.2%</td></tr><tr><td>% improvement in TSS</td><td>42.0%</td><td>36.4%</td><td>50.7%</td><td>48.6%</td></tr></tbody></table>

**CONCLUSIONS/FUTURE DIRECTIONS:** GES results in significant and sustained improvement in symptoms and quality of life in patients suffering of refractory gastroparesis. Certain patient subgroups with gastroparesis undergoing GES have different symptom outcomes. Additional factors that may predict outcomes for GES are needed.

### ETP009

### AN OFFICE BASED SYSTEM FOR ACCESSING IMPLANTED PORTS, James Ellsmere MD, Daniel B Jones MD, William

Wells PhD, 1. Department of Surgery, Beth Israel Deaconess Medical Center, Boston MA, 2. Department of Radiology, Brigham and Women's Hospital, Boston MA

**Objective:** We have found that a significant number of patients following laparoscopic adjustable gastric banding (LAGB) require fluoroscopy to make adjustments. We are developing a system that enables clinicians to access LAGB ports in a safe and reliable manner that it is easily accomplished in an office setting without imaging system support.

**Description:** The system consists of two major components: one is an external device called the port locator and the other is a device called the beacon. The beacon is a passive device that is attached to the port at the time of implantation. It is energized by magnetic induction and then emits a signal that is used by the port locator to determine the relative location of the port and the optimal angle to approach it. The feedback from the port locator to the clinician performing the port access is visual. The visual feedback allows the user to position and orient the needle such that it facilitates port access.

**Preliminary results:** The approximate characteristics of the current prototype are operating range: 10 cm, position accuracy: +/- 3.0 mm and angular accuracy: +/- 5 degrees. In our current testing environment, we have found the system can facilitate port access at multiple port depths and orientations.

**Future direction:** We are developing a more transparent user interface as well as a more sophisticated testing environment to better quantify the system performance characteristics and to train clinicians. Subsequently, we plan to proceed to animal testing to further assess safety and effectiveness.

### ETP010

### THE DISCRIMINATION OF EXPERT AND NOVICE SURGEONS BASED ON PREFRONTAL CORTICAL ACTIVATION

DURING A TECHNICAL SURGICAL TASK, Daniel R Leff

BS, Julian J Leong BS, Louis Atallah PhD, Thanos Athanasiou PhD, Peck Hui-Koh, Clare E Elwell, David t Delpy, Guang-Zhong Yang PhD, Ara Darzi MD, Imperial College London and University College London

**OBJECTIVE OF THE DEVICE:** Our aim is to "shed light" on the neurocognitive mechanisms associated with expertise development in surgery. Specifically, we are interested in the potential role that neuroimaging may have in explaining variations in longitudinal technical skills acquisition. Optical topography (OT) is a functional neuroimaging technique that utilizes near infrared (NIR) light to non-invasively quantify the haemodynamic response to neuronal brain activation. The degree to which cortical regions are recruited during the execution of complex tasks can be measured non-invasively using OT. Unlike other neuroimaging techniques OT, is portable, discreet, tolerant to body motion artefact and allows subjects to be evaluated in realistic settings.

**DESCRIPTION OF THE TECHNOLOGY:** NIR light is capable of penetrating biological tissues and can still be detected after absorption and scattering on the cortical surface. The dominant absorbers of NIR light in biological tissue are oxyhaemoglobin (HbO2) and deoxyhaemoglobin (HHb) and attenuated light levels can be converted into relative changes in these chromophores. The typical haemodynamic response in functionally activated tissue consists of a task-induced increase in HbO2 coupled to a decrease in HHb. Commercially available spectrometers emit light at multiple NIR wavelengths and provide haemodynamic data at several cortical measuring positions.
**PRELIMINARY RESULTS:** 62 healthy, right-handed male subjects (22 novices, 40 surgeons) participated in a study of open surgical knot tying in a bench-top environment. Medical students were subjected to a condensed didactic knot tying training session prior to the evaluation. A block design experiment was conducted involving episodes of self-paced surgical knot tying interspersed with episodes of motor rest. Optical responses were recorded from both prefrontal cortices using an OT imager [ETG-4000, Hitachi, Japan]. Surgical dexterity was measured using the Imperial College Surgical Assessment Device (ICSAD). Surgeons were significantly faster (p=0.000), used shorter pathlengths (p=0.000) and made fewer unnecessary movements (p=0.000) to complete trials than medical students. Significant haemodynamic patterns of brain activation were only isolated in the left prefrontal cortex in medical students and not in expert surgeons. Surgical knot tying evokes a lateralised brain response in novices, possible reflecting error detection and online monitoring of performance.

**FUTURE DIRECTIONS:** Future evaluation aims to assess the 'neuroplasticity' associated with protracted technical skills acquisition to determine whether prefrontal activation wanes in the context of learning success in surgery.

## ETP011

### CLINICAL APPLICATION OF A NOVEL GASEOUS AIRWAY REFLUX DETECTOR IN INFANTS AND CHILDREN, Chris Landon MD, Ventura County Medical Center

We undertook assessment of the use of a hypopharyngeal sensor for detection of laryngopharyngeal reflux in infants and children. Gastric reflux in the airway, or supraesophageal reflux, commonly takes a gaseous form that cannot easily be measured using conventional technology. The miniaturized pH sensor at the tip of the Dx-pH Probe is the only sensor able to measure pH in the airway. Fifteen infants and children referred to the Pediatric Pulmonary Center for assessment of chronic cough, hoarse voice, or uncontrolled asthma unresponsive to usual medical intervention underwent 6-48 hour to placement of the Dx-pH probe in supplementation of radiologic assessment of gastresophageal reflux. The probe was placed transnasally and visualized in the hypopharynx with the red light at the tip. Drops in pH <5 were correlated with food and symptom diaries.

<figure><img src="image_204.png" /></figure>

Positive results were found in 10/15 patients, leading to surgical intervention in three patients. Negative results led to changes in medical therapy. The device was tolerated in 13/15 patients with early removal in one young adult with endstage neuromuscular disease and in an infant with &quot;colic&quot; due to a hysterical parental reaction. As a result of our experience we have incorporated the use of supraesophageal pH monitoring into our practice, with particular attention to infants with persistent asthma and children with histories suggestive of gastric asthma. We have now incorporated it into our Vivometrics LifeShirt, an ambulatory physiologic monitoring device which will allow us to examine supraesophageal pH and its relationship to sleep apnea, cough, tachycardia, tachypnea, and hypoxemia.

## ETP012

### NATURAL ORIFICE ROBOTIC SURGERY: DA VINCI? LONGO TECHNIQUE DESCRIPTION, Adrian LOBONTIU MD, Daniel RABREAU MD, Paul-Henri CUGNENC MD, Claude TAYAR MD, Daniel LOISANCE MD, (1)Henri Mondor Hospital - Créteil, Paris XII, France and (2)European Hospital Georges Pompidou - Paris, France

The endolumenal surgery has tremendously been developed these last few years. So has been the robotic surgery.

By combining these two recent innovative developments we may solve some limitations and open new horizons and indications in surgery.

This work describes the Longo technique performed with the aid of the da Vinci Surgical Robot through natural orifices (trans-anal approach).

The degrees of freedom in rectal endolumenal surgery are limited because instruments need to be long and are manipulated through limited anatomy area.

In order to solve these limitations tools have been developed that have an articulation at the tip, which increases the degrees of freedom. Computer assistance is warranted, as the human brain cannot efficiently manipulate articulated instruments by mechanical means.

The surgeon sits comfortably at a master console located at a distance from the patient with eyes focused down toward the operative site, mirroring an open surgical technique.

The anal canal is exposed by placing 3 robotic trocars in triangulation, transanal, at the level of the sphincter.

By manipulating the joysticks at the console, all movements are transmitted in real time at the tip of the articulated instruments while the surgeon navigates with the Camera inside the rectum. The 3D stereoscopic vision is 15 times magnified.

The computer allows different scale motions set ups, filtering in mean time any involuntary trembling of the surgeon's hand.

Advantages of this technique consists in: better control for gaps of the stapler line; better inspection of bleeding points; optimal robotic hemostasis; outstanding accuracy in placing the pursestring suture: the needle is at the level of the mucosa, avoiding in this way any possible recto-vaginal or recto-urethral fistula due to including too much tissue.

We believe that endolumenal surgery and robotic surgery can develop together in a complimentary way. We continue to explore this exciting field and obtain more data for the work described.

The future is the one of robotic surgery but also the one of endolumenal surgery. By combining these two new trends in surgery we believe that new surgical indications will occur.

## ETP013

### RADIOFREQUENCY ABLATION OF LIVER TUMORS: A NOVEL NEEDLE PERFUSION TECHNIQUE ENHANCES EFFICIENCY, Paolo Abitabile MD, Christoph A Maurer MD, Kantonsspital Liestal, Switzerland, Clinic for General, Visceral, Thoracic and Vascular Surgery

**Objective:** Radiofrequency ablation (RFA) has become an important adjunct to modern liver surgery. Usually, the ablation is time-consuming due to charring around the electrodes. This charring increases the tissue impedance and hinders the propagation of the radiofrequency waves within the tumorous tissue. We hypothesize that an open saline perfusion of the RFA needle might help to overcome this problem and allow faster ablations.

**Methods:** From June 2000 to November 2004, a total of 159 liver tumors were treated during 95 sessions of RFA. Fifty-four tumors were treated according to the proposed manufacturer's protocol and compared with 105 tumors treated according to the novel saline perfusion protocol (0.9% saline solution). The ablation procedure was performed until a tissue temperature of at least 100°C was reached at every electrode tip for at least 5 minutes. The ablation area had to exceed the tumorous area for at least 1 cm to all sides. All the patients were followed up with contrast enhanced computed tomography (CT) at regular intervals. Local hepatic recurrence was defined as radiologic and/or histologic evidence of viable tumor in the ablated liver area.

**Results:** Both study groups were comparable especially with regard to median tumor sizes, mode of interventional approaches and times of follow-up. The median follow-up was 18 months. The median RFA time was significantly reduced from 18.9 minutes in the group without needle perfusion to 8.0 minutes in the group with needle perfusion (p<0.001). The local recurrence rate at the RFA site was tentatively higher in the non-perfusion group than in the per-
<figure><img src="image_205.png" /></figure>

# SAGES EMERGING TECHNOLOGY POSTER ABSTRACTS

fusion group (9.6% vs 5.8%, p=0.405). No recurrence occurred at the ablation site of tumors smaller than 3 cm in either group.

**Conclusion:** The perfusion of an expandable radiofrequency needle with 0.9% saline solution significantly accelerates the ablation procedure of liver tumors without compromising the oncosurgical result.

This technical improvement of RFA may render this treatment modality more attractive for surgeons.

## ETP014

**REBOUND HRD (HERNIA REPAIR DEVICE), Roderick B Brown MD**, Glacial Ridge Health System, Minnesota Medical Development Inc.

The Rebound HRD a new era in tension-free laparoscopic hernia repair.

by: Roderick Brown, M.D.

The Rebound HRD (Hernia Repair Device) was developed with the objective of improving upon existing technologies and methods used to repair various types of hernias. The Rebound HRD is a self-expanding hernia patch that helps to facilitate placement and coverage of a hernia defect. The Rebound HRD consists of an implantable polymer mesh with a Nitinol frame. The Nitinol frame supports and stabilizes the mesh and facilitates placement. The Rebound HRD is designed to be loaded into the supplied loading cannula and introduced using a 10mm - 12mm access port. The Nitinol frame is extremely durable and provides stability; eliminating the need for anchoring, which in turn, minimizes patient post-op discomfort and the risk of injury to nerves or blood vessels. Although the Rebound HRD is ideally suited for laparoscopic surgery it may also be placed via an open incisional approach using the same dissection and positioning methods described for the laparoscopic technique. Once deployed, the device fully unfurls or "rebounds" back to its original shape - ready for placement over the previously dissected hernia defect. The Rebound HRD has undergone MRI testing, an animal study and bench testing for burst strength, deployment and fatigue. Results for all tests were acceptable, meeting any pre-established acceptance criteria. During the 90-day animal study, laparoscopic deployments of the Rebound HRD were performed without any complications. All of the devices were easily distinguishable via x-ray. X-ray evaluation was able to confirm that there was no gross movement for any of the devices from their initial placement site. The assessment of the intranscience of the devices confirmed that the mesh held firmly to the Nitinol wire frame and that the original shape of the frame was preserved. Tissue reaction surrounding the cable, mesh and coupling was as expected with an implantable device and surface orientation had no discernable effect on the outcome. Specific patient and surgeon needs addressed with this new technology are:

- Shorter operating times

- Reduce the risk of vascular or nerve injury

- Eliminating fixation

- Minimizing patient post-operative discomfort

## ETP015

**TEM AS A PORTAL FOR NOTES, P M Denk MD, M H**

Whiteford MD, L L Swanstrom MD, Legacy Health System, Portland, OR

The potential of natural orifice surgery has excited the surgical community worldwide. Appropriate concerns over safe access and closure of transvisceral enterotomies have made many believe the technology is far from clinical use. Natural orifice translumenal endoscopic surgery (NOTES) is most commonly described using a transgastric access point however retroflexion for tasks in the upper abdomen results in significant perception and manipulation difficulties. We are actively investigating transrectal access for natural orifice surgery which offers the advantage of antegrade visualization of surgical sites in the upper abdomen. This avoids the technical challenge of horizon shift and maintains strong spatial orientation.

We present the use of transanal endoscopic microsurgery (TEM) as a portal for transrectal NOTES. TEM techniques for

full-thickness resection, closure, and even circumferential rectal anastomosis have been used clinically in humans for two decades. Entry into the abdomen following resection of upper rectal lesions is routinely performed and has been demonstrated to be safe.

The modular design of the TEM instrumentation offers the potential for rapid modification to incorporate future NOTES devices. The 4 cm diameter of the TEM scope offers sufficient room for the introduction of multiple rigid or flexible instruments. The TEM scope provides a stable platform to lift organs and manipulate tissue, difficult tasks for simple flexible instruments. Maintaining CO2 pneumoperitoneum is predictable, accurate, and facile with the TEM insufflator. Finally, TEM techniques allow a careful surgical closure of full-thickness rectotomies using standard suture with laparoscopic suturing techniques.

Our presentation will demonstrate of the benefits of TEM as a portal for NOTES including endoscopic views and surgical task performance through transrectal access, and secure rectal closure.

## ETP016

**LAPAROSCOPIC UMBRELLA SYSTEM FOR MESH PLACEMENT IN VENTRAL HERNIA, Brij B Agarwal, Nayan**

Agarwal, Krishna A Agarwal, Manish K Gupta MS, Sneh Agarwal MS, Krishan C Mahajan MS, Sir Ganga Ram Hospital, Lady Hardinge Medical College & DPS, RK Puram, India

**OBJECTIVE**- To achieve scientific Introduction, unrolling, centering & mesh fixation in laparoscopic ventral hernia repair (LVHR). **DESIGN**- Based on mechanics of an umbrella(1). Introduction is like pushing a closed umbrella through port(A) leaving mesh(B) in and pulling out the remaining umbrella. A central rod with mettalic, flexible spokes attached by a movable joint to its tip. The central rod has a lever to close or open the joint to 90 degree. Length of spoke is equal to the radius of a circular mesh (1). The spokes sleeve through loops arranged radially on the parietal surface of mesh(2).

**METHOD of application**-Mesh is radially sleeved on spokes which are folded back on the central rod as closed umbrella. This is introduced(2), joints opened to 90 degree. The mesh opens up and is spread parallel to the abdominal wall (AW). Instrument is slightly withdrawn till mesh is in contact with AW(3). Mesh securing tackers placed(4). The instrument is withdrawn leading the spokes out of loops on parietal surface of mesh(5). Mesh is now transfixed. This is combined with "Pant over Vest" repair in LVHR (abstract ID. 14215) to comply with Pascal's law.

**FUTURE DIRECTION**-This ensures easy introduction without skin/hand contact, wrinkle free unfolding & centering of the mesh. Avoiding contamination or harmful manipulation of mesh on the visceral surface.

<figure><img src="image_206.png" /></figure>

## ETP017

**NATURAL ORIFICE TRANSLUMENAL SURGERY: LONG TERM SURVIVAL STUDY AFTER CLOSURE OF THE GASTROTOMY USING A CARDIAC SEPTAL OCCLUSION IN A PORCINE MODEL, Silvana Perretta MD, Bernard Dallemagne**
MD, Stefano Sereno MD, Antonello Forgione MD, Dimitri Coumaros MD, Christof Boosfeld, Jacques Marescaux MD, IRCAD-EITS. University of Strasbourg. France/ * DRABO / Occlutech, Germany

**Introduction:** Transgastric approach to the peritoneal cavity has been proved to be feasible both in experimental models and in humans. The closure of the gastrotomy when performing transgastric procedures is one of the most challenging step to overcome.
<figure><img src="image_207.png" /></figure>

**Aim:** The aim of this study was to evaluate the technical feasibility, safety and long term efficacy of a new endoscopic method of gastric closure using a nitinol septal occluder in a porcine survival model.

**Materials and Methods:** Using a single channel video gastroscope, a 1 cm full thickness gastrotomy was created to access the peritoneal cavity in six anaesthetised male pigs (25-30kg), after gastric preparation. After peritoneoscopy, the gastrotomy was closed with a nitinol septal occluder. The efficacy of the closure was tested intraoperatively inflating the stomach under laparoscopic and endoscopic control. All animals were survived and monitored daily. Follow-up included iterative laparoscopy (4) and gastroscopy(8). Necropsy was performed at week 15 and included bacteriologic study of intraperitoneal liquid, inspection of adhesions, air leak testing and histopathologic examinations of the stomach.

**Results:** All the gastrotomy closures with the septal occluder were successful with a mean positioning time of 15 min. A regular diet was resumed within 24 hours after the procedure. There were no complications in the immediate postoperative course. One animal developed clinical signs of distress and stopped feeding on postoperative day 12th. The necropsy revealed peritonitis, unrelated to the gastric closure. At a 15 weeks follow-up five of the six animals thrived with appropriate weight gain. The post-mortem examination revealed no signs of infection or adhesions in the peritoneal cavity with normal tissue healing around the occluder at the histopathologic examination.

**Conclusions:** Endoscopic gastrotomy closure with the septal occluder system is technically feasible, safe and effective in a long-term survival porcine model. This gastrotomy closure device has shown enormous potentials being highly effective, rapid and simple.

## ETP018

**THE EFFECT OF A COMPRESSION MECHANISM ON ENERGY BASED VESSEL SEALING**, Marc Singer MD, Linda S Oleson, University of Illinois, Chicago, SurgRx, Inc.

**Objective of the technology:** Improve vessel sealing by combining a compression mechanism with a proprietary thermal energy device. Mechanism provides uniform pressure along the full length of the seal, or tissue treated, to achieve a thorough and durable vessel fusion. In addition, this mechanism may help to minimize destructive thermal effects to the surrounding tissues.

**Description of the technology and method of its use or application:** The compression mechanism consists of a metal structure in the shape of an "I-beam" with the cross section of a capital "I", namely, an "I-Blade". The distal and vertical edge of the I-Blade mechanism is sharpened to act as a blade that transects tissue. When used in conjunction with the proprietary electrode configuration of a bipolar radiofrequency vessel sealer, the I-Blade mechanism compresses the targeted volume of tissue as the tissue descicates and the collagen denatures or "melts". The I-Blade advances smoothly through the melted tissue as the handle grip is squeezed, dividing the tissue in its path to the distal end of the jaw. The forward motion of the I-Blade simultaneously draws the top and bottom jaws parallel to compress and cut the captured tissue in the jaws, creating a newly formed seal. The collagen immediately cools in the new sealed configuration.

**Preliminary results:** The maximum compression force during I-Blade advancement is above 7,000 PSI. This instrument is capable of producing seal strengths upwards of 7 times normal systolic pressure. With regards to thermal effects, information on collagen denaturation can be found in the literature which suggests that mechanical loads on tissue minimize the destructive effects of heat on tissue.

**Future directions:** Though acute studies on the histopathologic effects of thermal vessel sealing can be found in the literature, the cytologic manifestations of tissue injury don't fully develop until after 36 to 48 hours. To truly evaluate the thermal effects of compression from the I-Blade on treated tissue, a chronic study should be done, and the thermal effects compared and evaluated.

## ETP019

**PRELIMINARY REPORT OF A NOVEL GASTRIC SENSING AND ELECTRICAL STIMULATION DEVICE TO TREAT OBESE SUBJECTS WITH T2DM**, John Pilcher MD, Mark Kipnes MD, Edy Soffer MD, Jeffrey Conklin MD, Scott Cunneen MD, Diabetes and Glandular Disease Research Associates, Inc. San Antonio, Texas and Cedars Sinai Medical Center, Los Angeles, California

**Background:** Gastric electrical stimulation represents a new paradigm for treating obesity and diabetes. The following describes a feasibility study of an investigational device, the TANTALUSTM System (Metacure (USA) Inc.), intended for use in obese and overweight subjects with type 2 diabetes. The system uses automatic detection of food intake and delivers electrical pulses synchronized to the natural gastric activity. This multi-center study is conducted with an FDA/IRB approved IDE.

**Methods:** The study design includes 16 obese/morbidly obese subjects, with a BMI between 30 and 45kg/m2 and HbA1c between 7.5% and 9.5%. The therapy is initiated four weeks post-surgery for 12 weeks with periodic evaluations of HbA1c, fasting blood glucose, weight, serum Adiponectin and Ghrelin measurement. The patients will be monitored for safety and functionality of the device for an additional 18 months.

**Results:** To date, 3 subjects have been implanted with automatic eating detection successfully demonstrated in the two subjects who have started therapy. Data representing measures of safety and functionality will be presented consisting of adverse events, measures of glycemic control, changes in weight and the hormones Ghrelin, Adiponectin and GLP-1. Conclusion: Recruitment of subjects into this multicenter feasibility study of an investigational gastric sensing and electrical stimulation device to treat obese or over-weight subjects with T2DM is on-going. Preliminary safety and functionality data will be presented from all study subjects.

## ETP020

**ENDOLUMINAL APPROACHES TO BARIATRIC SURGERY; A NEW APPLICATION OF THE MODIFIED NDO PLICATOR**, Carol A McCloskey MD, Anita P Courcoulas MD, Amos Cruz, George Eid MD, University of Pittsburgh Medical Center and the VA Health Care System

Endoluminal interventions are undergoing rapid evolution. Our current interest is the application of this approach to the field of bariatric surgery. Although Roux-en-Y gastric bypass is an effective treatment of morbid obesity, many patients regain weight over time; an outcome thought to be due to dilation of the gastrojejunal (GJ) anastomosis. Surgical reduction of the anastomoses has been performed with variable results, but it is a complex operation, with a high complication rate. Therefore, we attempted to assess the safety and feasibility of utilizing the NDO plicator device to perform an endoscopic anastomotic reduction.

The current NDO plicator is an FDA approved endoluminal suturing device applied to the treatment of GERD. The NDO plicator is a suturing device with opposing jaws between which a pre-tied suture is deployed. It contains a channel through which a small endoscope is passed in order to directly visualize the suturing process. It currently utilizes an accessory device that fits through a side channel and functions to anchor the tissue. This device is a spiraling wire that directly screws into the tissue, retracting it between the jaws of the plicator, allowing a full thickness bite. However, this device is unable to grasp two opposing tissue surfaces at once. We therefore devised an additional flexible grasper that fits through the same side channel of the plicator. It has opposing teeth that allows the device to be advanced through the side channel, with the ability to open once deployed in a lumen or a tissue space, and is able to grasp two opposing tissue edges tightly, facilitating suture placement by the device.

We have performed GJ stomaplasty on 10 pigs. By using the new grasper prototype, we were able to successfully deploy sutures that reduced the aperture of the GJ anastomosis. No intraoperative complications were encountered
<figure><img src="image_208.png" /></figure>

during the procedure. In addition, when the stoma was completely closed in several animals, the sutures were able to withstand 50mmHg of burst pressure. These experiments were documented by video footage.

Our results have demonstrated that endoluminal stomaplas- ty using our modification of the NDO plicator device is tech- nically feasible. Future studies will include survival studies to assess the effect on weight loss. This technique may also be applicable to the repair of gastro-gastric fistulae and/or anastomotic leaks. Ultimately, application to human bariatric patients will represent a safer alternative to revisional sur- gery.

## ETP021

### DEVELOPING AN ULTRASONIC PROBE FOR TUMOR ABLATION IN LIVER: EXPERIMENTAL RESULTS WITH MORPHO-LOGICAL ANALYSIS OF THE ULTRASONIC LESIONS.

Belhassen Seket MD,Cyril Lafon PhD,Rares Salomir PhD,François Mithieux MD,Jean-Yves Chapelon PhD,Michel Rivoire MD,Dominique Cathignol PhD, Insitut National de la Santé et de la Recherche Médicale (INSERM) unité 556, Université Claude Bernard - Iyon 1 and Centre Léon Bérard (Institut de Chirurgie Expérimentale) , Lyon, France.

Main existing thermal ablation techniques gave satisfactory results for tumors of no more than 3 cm in diameter. The aim of our work was to develop an ultrasonic probe for interstitial liver ablation, to check its destructive capabilities and define the ultrasonic parameters to obtain large areas of tissue destruction.

An ultrasonic probe, 4 mm in diameter, which is fitted with a flat piezoceramic transducer is developed for experimental applications. A pneumatic support, which holds the probe positioned in the liver, is fitted with a rotation device allow- ing a computer-controlled rotation of the probe around its axis.

The array element causes immediate necrosis which size is altered very little by the cooling effect due to blood flow. Two types of lesions were obtained: elementary and cylin- drical lesions. At a given angular position, the single shot induces an elementary lesion whose length can be adjusted according to several parameters. In a first study, we obtained without pedicle clamping elementary lesions of 29 mm in mean length. Rotation of the transducer at short angular intervals resulted in the fusion of elementary lesions and gave a cylindrical lesion. The step-by-step mode of rotation was superior than the continuous mode in terms of rapidity and size of lesions. The cylindrical ablation areas were of 50 cm? in mean volume and of 56 mm in mean length and presented well-defined contours. Histological analysis showed complete coagulation even around large vessels when efficient ballistics was used.

These results are encouraging and further improvements are quite possible. At the difference of the other techniques, the ultrasonic probe give bigger ablation areas and more possibilities to adapt our application to the target zone. Transducers capable to integrate at the same time ultra- sound imaging and therapy may offer more precision and options, such as the use of ultrasound contrast agents may be useful to treat large tumors.

## ETP022

### DEVELOPMENT OF HYBRID SURGICAL SIMULATION DEVICE, Cronwel N Irias, Daniel A Hashimoto, Daniel M

Jones MD, Beth Israel Deaconess Medical Center Human Patient Simulators (HPS) allow for the performance of basic clinical and trauma procedures using a team train- ing approach. Partial and whole task training simulators measure metrics of performance that human patient simula- tors do not. The abdominal model combines existing low- fidelity partial task simulation technology and human patient simulators to create a high-fidelity simulation. The model was developed using a chassis to house the perfus- ing organs and provide a sealed pneumoperitoneum.

<figure><img src="image_209.png" /></figure>

Features within the METI Human Patient Simulator&#x92;s hardware and software provided programming of perfusion to the abdominal model allowing the recreation of internal hemorrhage; conversion to open to control hemorrhage is possible. As simulation technology evolves, new methods of creating immersive simulation education and training opportunities can provide realistic surgical training. HPS Abdomen provides for engaging performance of laparo- scopic and open surgery. Our aim was to develop a hybrid simulation training device, HPS Abdomen, to allow sur- geons to experience a more immersive role during team training based simulation for laparoscopic and open proce- dures and is a foundation for more complex scenarios.

## ETP023

### PILOT STUDY ON THE EFFECTS OF GASTRIC ELECTRICAL STIMULATION (TANTALUS) ON GLYCEMIC CONTROL IN MORBIDLY OBESE PATIENTS WITH TYPE 2 DIABETES

(T2DM), Arthur Bohdjalian MD,Bernhard Ludvik MD,Rudolph Weiner MD, Christoph Rosak MD, Gerhard Prager MD, Medical University of Vienna, Dept. of Surgery and Internal Medicine III; Krankenhaus Sachsenhausen Frankfurt, Dept. of Surgery and Internal Medicine

**Background:** Previous work suggests that non-excitatory electrical stimulation, synchronized to the gastric refractory period and applied during meals, can induce weight loss in morbidly obese subjects. The TANTALUS System (MetaCure N.V.) is a minimally invasive implantable gastric stimulation modality that does not exhibit malabsorptive or restrictive characteristics.

**Aim:** to investigate the potential effect of the TANTALUS system on glycemic control and weight in morbidly obese subjects with T2DM.

**Patients and Methods:** In this European multi-center, open label study, 24 T2DM obese (9 m, 15 f, BMI: 41.7±0.9 kg/m2) subjects treated either with insulin (7) or oral anti-diabetic medications (17) were implanted laparoscopically with the TANTALUS System. The system includes a pulse generator and three bipolar leads and delivers a non-excitatory signal initiated upon automatic detection of food intake. Results: 20 subjects have completed one year and exhibit a decrease in HbA1c from 8±0.2% at baseline to 7.5±0.2% (p=0.06) and in fasting blood glucose from 180±15mg/dl to 150±8mg/dl (p<0.05). 16 subjects on oral anti-diabetic medications showed a decrease in HbA1c from 8.11±0.3% at baseline to 7.37±0.2% (p<0.05) and an average weight loss of 5.5±2kg (p<0.05). Self glucose monitoring available at 9 months post-op from 12 subjects shows a significant (p<0.05) decrease in 2 hours post-prandial glucose (184±11mg/dl vs.148±11mg/dl).In a subset of 9 patients at 9 months of post-operative follow-up we could find an increase in adiponectin (9.5±2.3 vs. 11.5±2.3µg/ml, p<0.05) and a decrease in fasting ghrelin (428±80 vs. 252±20pg/ml, p<0.05). Four insulin subjects have completed one year and showed no significant changes in HbA1c and weight.

**Conclusion:** Interim results with the TANTALUS System sug- gest that this stimulation regime can potentially improve glucose levels and induce weight loss in obese T2DM sub- jects on oral anti-diabetic therapy. Further evaluation is required to determine whether this effect is due to induced weight loss and/or due to direct signal dependent mecha- nisms.