Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.

NCT ID: NCT00940264

Last Updated: 2012-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cholecystolithiasis Cholecystitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Given indication for cholecystectomy

transvaginal hybrid cholecystectomy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* given informed consent for transvaginal hybrid cholecystectomy

Exclusion Criteria

* pregnancy
* malignoma
* present choledocholithiasis
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ignazio Tarantino

OTHER

Sponsor Role lead

Responsible Party

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Ignazio Tarantino

M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andreas Zerz, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital St. Gallen

Locations

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Department of surgery

Sankt Gallen, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EKSG08/060/2B

Identifier Type: -

Identifier Source: org_study_id

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