Clinical Trial: Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University Hospitals Cleveland Medical Center

Current Primary Outcome: 30 day Post-op NOTES feasibility outcomes: [ Time Frame: 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


Original Primary Outcome:

Current Secondary Outcome:

  • 30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery [ Time Frame: 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 [ Time Frame: 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


Original Secondary Outcome:

Information By: University Hospitals Cleveland Medical Center

Dates:
Date Received: June 7, 2007
Date Started: August 2006
Date Completion:
Last Updated: December 12, 2014
Last Verified: December 2014