NCT00940264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 13, 2012

Status Verified

February 1, 2012

Enrollment Period

2.6 years

First QC Date

July 14, 2009

Last Update Submit

February 10, 2012

Conditions

CholecystolithiasisCholecystitis

Keywords

symptomatic cholecystolithiasis

Outcome Measures

Primary Outcomes (1)

  • Feasibility and safety of the transvaginal operation

    30 days

Secondary Outcomes (1)

  • Long-term life quality and sexual dysfunction

    3 year

Study Arms (1)

Given indication for cholecystectomy

Procedure: transvaginal hybrid cholecystectomy

Interventions

transvaginal hybrid cholecystectomyPROCEDURE

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.

Given indication for cholecystectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

female patiens with given indication for cholcystectomy

You may qualify if:

  • given informed consent for transvaginal hybrid cholecystectomy

You may not qualify if:

  • pregnancy
  • malignoma
  • present choledocholithiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of surgery

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

CholecystolithiasisCholecystitis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Officials

  • Andreas Zerz, MD

    Cantonal Hospital of St. Gallen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

September 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

February 13, 2012

Record last verified: 2012-02

Locations

CH(1)