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Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ignazio Tarantino, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00940264
First received: July 14, 2009
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Cholecystolithiasis
Cholecystitis
 Procedure: transvaginal hybrid cholecystectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Feasibility and safety of the transvaginal operation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long-term life quality and sexual dysfunction [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: September 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

female patiens with given indication for cholcystectomy

Criteria

Inclusion Criteria:

  • given informed consent for transvaginal hybrid cholecystectomy

Exclusion Criteria:

  • pregnancy
  • malignoma
  • present choledocholithiasis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940264

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

No publications provided

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
Study First Received: July 14, 2009
Last Updated: February 10, 2012
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on May 22, 2013