Technical Feasibility of Routine Intraoperative Cholangiography During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy

Completed

• Conditions: Gallstone Disease
• Interventions: Procedure: Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy

• Registration Number: NCT01583348
• Lead Sponsor: Cantonal Hosptal, Baselland

Brief Summary

While gold standard in the treatment of symptomatic gall stones is laparoscopic cholecystectomy with instruments introduced through multiple abdominal wall incisions, transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective and safe. However it has not been demonstrated up-to-date if intraoperative cholangiography is feasible during such procedure. This observational case series describes success and technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy. The investigators hypothesis is that cholangiography is feasible equal to conventional laparoscopic cholecystectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Primary Completion: 2012-10
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-28
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• symptomatic gallstone disease
• age > 18 years
• written informed consent

Exclusion Criteria

• age < 18 years
• not able to understand informed consent
• pregnancy
• vaginal atresia
• florid vaginal infection
• gynecological neoplasia
• allergy to Iod
• missing informed consents
• emergency procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with gallstones	Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy	30 women with symptomatic gallstone disease with an indication for elective cholecystectomy

Primary Outcome Measures

Name	Time	Method
Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no)	intraoperative	Was the introduction of the cholangiography catheter into the cystic duct successfull during transvaginal rigid-hybrid cholecystectomy.

Secondary Outcome Measures

Name	Time	Method
Time required for cholangiography	intraoperative	From incision of the cystic duct to clipping of the cystic duct
Intraoperative complications	intraoperative
postoperative complications	within 6 weeks from surgery

Trial Locations

Locations (1)

Cantonal Hospital Baselland, Bruderholz, Department of Surgery; 🇨🇭 Bruderholz, Baselland, Switzerland