Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

Phase 3

Completed

• Conditions: Cholelithiasis
• Interventions: Procedure: Transvaginal hybrid NOTES cholecystectomy; Procedure: Cholecystectomy

• Registration Number: NCT00835250
• Lead Sponsor: Hospital Son Llatzer

Brief 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Primary Completion: 2011-05
• Study Completion: 2012-04
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• age over 18 and under 65
• symptomatic cholelithiasis with an indication for performing laparoscopic surgery
• absence of any gynecological condition that could complicate the procedure (pelvic inflammatory disease or endometriosis)
• perforated hymen
• agreement on the patient's part not to use the vagina for two weeks after the surgery
• signed specific informed consent upon providing specific information about the new surgical approach.

Exclusion Criteria

• age under 18 or over 65
• unperforated hymen
• presence of illness or condition with an increased risk of pelvic damage with transvaginal approach.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transvaginal	Transvaginal hybrid NOTES cholecystectomy	Transvaginal endoscopic cholecystectomy
Laparoscopy	Cholecystectomy	Laparoscopic cholecystectomy
Transumbilical	Cholecystectomy	Transumbilical endoscopic cholecystectomy
Transvaginal	Cholecystectomy	Transvaginal endoscopic cholecystectomy

Primary Outcome Measures

Name	Time	Method
Parietal complications after surgery (infection and hernia)	One year

Secondary Outcome Measures

Name	Time	Method
Surgical pain. General complications. Patient's preferences.	One year

Trial Locations

Locations (1)

Hospital Son Llàtzer; 🇪🇸 Palma de Mallorca, Illes Balears., Spain