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Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.

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ClinicalTrials.gov Identifier: NCT00940264
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : February 13, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cholecystolithiasis Cholecystitis Procedure: transvaginal hybrid cholecystectomy

Study Design

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2008
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Given indication for cholecystectomy 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.

Outcome Measures

Primary Outcome Measures :
  1. Feasibility and safety of the transvaginal operation [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Long-term life quality and sexual dysfunction [ Time Frame: 3 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
female patiens with given indication for cholcystectomy

Inclusion Criteria:

  • given informed consent for transvaginal hybrid cholecystectomy

Exclusion Criteria:

  • pregnancy
  • malignoma
  • present choledocholithiasis
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940264

Department of surgery
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Ignazio Tarantino
Principal Investigator: Andreas Zerz, MD Cantonal Hospital St. Gallen
More Information

Responsible Party: Ignazio Tarantino, M.D., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00940264     History of Changes
Other Study ID Numbers: EKSG08/060/2B
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012

Keywords provided by Ignazio Tarantino, Cantonal Hospital of St. Gallen:
symptomatic cholecystolithiasis

Additional relevant MeSH terms:
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical