Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery

Not Applicable

Completed

• Conditions: Gastric Foreign Body, Nos; Foreign Body in Esophagus; Disorder of Abdomen (Disorder); Prostatic Diseases; Disease of Small Intestine
• Interventions: Procedure: Natural Orifice Transluminal Endoscopic Surgery (NOTES); Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES)

• Registration Number: NCT00484783
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-06-07
• Study First Submitted QC: 2007-06-08
• Study First Posted: 2007-06-11
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-12
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective	Natural Orifice Transluminal Endoscopic Surgery (NOTES)	Subjects scheduled to receive procedure
Historical	Natural Orifice Translumenal Endoscopic Surgery (NOTES)	Chart review control group

Primary Outcome Measures

Name	Time	Method
30 day Post-op NOTES feasibility outcomes:	30 days post-op	* 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

Secondary Outcome Measures

Name	Time	Method
30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery	30 Day Post-OP	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 NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration	30 Day Post - Op	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

Trial Locations

Locations (1)

University Hospitals of Cleveland Case Medical Center; 🇺🇸 Cleveland, Ohio, United States