Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.

Completed

• Conditions: Cholecystolithiasis; Cholecystitis
• Interventions: Procedure: transvaginal hybrid cholecystectomy

• Registration Number: NCT00940264
• Lead Sponsor: Ignazio Tarantino

Brief Summary

Transvaginal hybrid procedures especially the transvaginal hybrid cholecystectomy are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety in a selected patient collective. The aim of this prospective data collection is to evaluate the feasibility in the clinical routine in a non select patient collective.

Therefore all patients giving the informed consent to the transvaginal hybrid cholecystectomy will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-10
• Last Update Posted: 2012-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• given informed consent for transvaginal hybrid cholecystectomy

Exclusion Criteria

• pregnancy
• malignoma
• present choledocholithiasis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Given indication for cholecystectomy	transvaginal hybrid cholecystectomy	-

Primary Outcome Measures

Name	Time	Method
Feasibility and safety of the transvaginal operation	30 days

Secondary Outcome Measures

Name	Time	Method
Long-term life quality and sexual dysfunction	3 year

Trial Locations

Locations (1)

Department of surgery; 🇨🇭 St. Gallen, Switzerland