Brief Title
Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.
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.
Study Type
Observational
Primary Outcome
Feasibility and safety of the transvaginal operation
Secondary Outcome
Long-term life quality and sexual dysfunction
Condition
Cholecystolithiasis
Intervention
transvaginal hybrid cholecystectomy
Study Arms / Comparison Groups
Given indication for cholecystectomy
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
200
Start Date
September 2008
Completion Date
April 2011
Primary Completion Date
April 2011
Eligibility Criteria
Inclusion Criteria: - given informed consent for transvaginal hybrid cholecystectomy Exclusion Criteria: - pregnancy - malignoma - present choledocholithiasis
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Andreas Zerz, MD, ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT00940264
Organization ID
EKSG08/060/2B
Responsible Party
Sponsor-Investigator
Study Sponsor
Ignazio Tarantino
Study Sponsor
Andreas Zerz, MD, Principal Investigator, Cantonal Hospital St. Gallen
Verification Date
February 2012