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OpenTrials
Completed

NCT Number: NCT00940264

Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.

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.

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Key information

Conditions

Cholecystolithiasis Biliary Tract Diseases Cholecystitis Cholelithiasis Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of surgery

Sankt Gallen, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • given informed consent for transvaginal hybrid cholecystectomy

Exclusion criteria

  • pregnancy
  • malignoma
  • present choledocholithiasis

Treatment and study plan

transvaginal hybrid cholecystectomy

Procedure

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.

Primary outcomes

  1. Feasibility and safety of the transvaginal operation

    Time frame: 30 days

Secondary outcomes

  1. Long-term life quality and sexual dysfunction

    Time frame: 3 year

Sponsors and collaborators

Lead sponsor

Ignazio Tarantino

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 15, 2009
Registry last updated
Feb 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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