NCT00486655

NOTES-Assisted Laparoscopic Cholecystectomy Surgery

Assisted Laparoscopic Cholecystectomy Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: USGI Medical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholelithiasis
• Cholecystitis

Interventions

Type	Name	Description
PROCEDURE	NOTES-Assisted Cholecystectomy

Timeline

• Start date: 2007-05-01
• Completion: 2007-06-01
• First posted: 2007-06-14
• Last updated: 2012-08-08

Locations

1 site across 1 country: United States