NCT00835250

Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

Prospective Randomized Clinical Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Endoscopic Surgery (NOTES)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hospital Son Llatzer · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).

Detailed description

Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. At the present time these procedures are hybrids. It is expected a better cosmetic result and lower incidence in parietal complications in front of laparoscopic cholecystectomy, but is necessary to investigate that these benefits should not be associated with complications of the new access to abdominal cavity. Methods. Prospective randomized clinical series of 60 female patients with gallstones that underwent endoscopic surgery, 20 of them operated with conventional laparoscopic approach, 20 by transumbilical endoscopic approach and 20 of them by transvaginal endoscopic approach. Variables as surgical wound infection, urinary tract infection, evisceration, hernia, mortality and other complications will be analyzed.

Conditions

• Cholelithiasis

Interventions

Type	Name	Description
PROCEDURE	Transvaginal hybrid NOTES cholecystectomy	Cholecystectomy performed by using a combination of working tools inserted through the entry port for the minilaparoscopy and the videogastroscope, inserted into peritoneal cavity by transvaginal approach. The gallbladder is removed transvaginally through the videogastroscope.
PROCEDURE	Cholecystectomy	Extirpation of the gallbladder by a surgical procedure

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-05-01
• Completion: 2012-04-01
• First posted: 2009-02-03
• Last updated: 2013-03-12

Locations

1 site across 1 country: Spain