NOTES-Assisted Laparoscopic Cholecystectomy Surgery

Not Applicable

Terminated

• Conditions: Cholecystitis; Cholelithiasis

• Registration Number: NCT00486655
• Lead Sponsor: USGI Medical

Brief Summary

This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.

Detailed Description

A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites.

A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.

Study Timeline

• Study Start: 2007-05
• Study Completion: 2007-06
• Study First Submitted: 2007-06-12
• Study First Submitted QC: 2007-06-13
• Study First Posted: 2007-06-14
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Ability to undergo general anesthesia
• Age >= 18 yrs. of age and <= 85 yrs. of age
• Ability to give informed consent

Exclusion Criteria

• Acute cholecystitis
• BMI >= 40
• Contraindicated for EGD
• Presence of common duct stones
• Presence of esophageal stricture
• Altered gastric anatomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality of Life	2 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of complications	2 weeks

Trial Locations

Locations (1)

Oregon Clinic; 🇺🇸 Portland, Oregon, United States