Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery

Study Overview
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Brief Summary
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NOTES access is safe and feasible in the controlled human setting and comparable to standard-of-care surgical techniques. NOTES exploration of the abdomen provides adequate visualization comparable to laparoscopy.

Detailed Description
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This is a prospective clinical trial to evaluate the feasibility of obtaining peritoneal cavity access from natural orifice translumenal endoscopic surgery (NOTES) during combined laparoscopic-endoscopic foregut surgery. Post-operative course will be compared with a historical chart-review control group of patients undergoing standard laparoscopic foregut and urologic surgery. The study group will be compiled by open enrollment for male and female adult subjects scheduled for combined laparoscopic-endoscopic surgery of the stomach, abdominal esophagus, prostate, bladder, proximal small intestine or who meet inclusion and exclusion criteria. The historical chart-review control group will be randomly chosen from patients from 2003-2006 having undergone combined laparoscopic-endoscopic surgery of the foregut, prostate, or bladder and as determined by CPT coding. The purpose of the study is to determine if NOTES access and abdominal exploration is feasible, safe, offers comparable visualization to laparoscopy in a controlled human setting.

Official Title
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Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery

Conditions
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Gastric Foreign Body, Nos, Disorder of Abdomen (Disorder), Foreign Body in Esophagus, Prostatic Diseases, Disease of Small Intestine

Intervention / Treatment
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* Procedure: Natural Orifice Transluminal Endoscopic Surgery (NOTES)
* Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing an already combined laparoscopic and endoscopic foregut procedure with general anesthesia Patients undergoing a prostatectomy or cystectomy with general anesthesia All patients will have a planned gastrotomy for exploration, foreign body removal, or removal of tissue, making it a contaminated case or a planned cystotomy or urethrotomy for exploration, foreign body removal or removal of tissue such as prostatectomy or bladder resection. No overwhelming medical co-morbidities Subject is 18 years of age or older Subject is his or her own medical decision maker Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form Exclusion Criteria: Patients undergoing a non-palliative procedure in the face of resectable adenocarcinoma of the foregut or genitourinary tract Linitis Plastica Evidence of Active Bowel Obstruction Patients with history of oropharyngeal, esophageal, or gastric adenocarcinoma. Esophageal stricture prohibiting passage of an endoscope Urethral stricture prohibiting passage of an endoscope Emergent Surgery At any time during pre-operative or intra-operative periods, evidence of unresectability is demonstrated Any intra-operative condition prior to surgical resection that results in abortion of the surgical procedure Any contraindication to surgery Pregnancy or actively breastfeeding women Prisoners or Wards of State

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective<br>Subjects scheduled to receive procedure | Procedure: Natural Orifice Transluminal Endoscopic Surgery (NOTES)<br>* Patients will have the standard laparoscopic procedure and the NOTES procedure will be added. The surgical procedure will require two operating teams: one led by a laparoscopic surgeon, the other by an endoscopic surgeon. During the usual course of the surgery, the flexible endoscope will be passed through the mouth urethra top gain access to the peritoneal cavity.<br>* Other names: NOTES Surgery;|
| Other: Historical<br>Chart review control group | Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES)<br>* chart review of historical data from control group<br>* Other names: NOTES Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day Post-op NOTES feasibility outcomes: | Number of successful NOTES access attempts Number of failed NOTES access attempts Injury to collateral organs or structures Time to gain access to peritoneal cavity Necessary balloon dilator size required for translumenal passage of endoscope | 30 days post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery | Description: Mortality Post-Op Mobidity repeat sugery Intra-Op or Post-Op RBC Transfusion Intra-Abdominal Abscess Superficial Surgical Site Infection Antibiotics>24th Post-Op Safety Issue?: Yes | 30 Day Post-OP | 
| 30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration | Description: Identification of Specified Abdominal and Pelvic Organs Time to Adequately Visualize Specified Abdominal and Pelvic Organs Comparitive findings between standardaized abdominal exploration between laparoscopy and NOTES techniques | 30 Day Post - Op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Surgical Procedures, Endoscopic Surgical Procedures, Laparoscopic & endoscopic procedures with a gastrotomy, or opening in bladder or urethra