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NCT00940264 Clinical Trial

Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.

Cholecystitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00940264
Other study ID # EKSG08/060/2B
Secondary ID
Status Completed
Phase N/A
First received July 14, 2009
Last updated February 10, 2012
Start date September 2008
Est. completion date April 2011

Study information
Verified date February 2012
Source Cantonal Hospital of St. Gallen
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- given informed consent for transvaginal hybrid cholecystectomy

Exclusion Criteria:

- pregnancy

- malignoma

- present choledocholithiasis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• transvaginal hybrid cholecystectomy
transvaginal hybrid cholecystectomy: using one trans-umbilical 5mm trocar and 2 (one 12mm trocar, one 5-mm trocar)inserted through the posterior colpotomy. Removal of the gallbladder through the transvaginal access.

Locations
Country Name City State
Switzerland Department of surgery St. Gallen

Sponsors (1)
Lead Sponsor Collaborator
Ignazio Tarantino

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility and safety of the transvaginal operation 30 days Yes
Secondary Long-term life quality and sexual dysfunction 3 year Yes
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