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Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00940264
Enrollment
200
Registered
2009-07-15
Start date
2008-09-30
Completion date
2011-04-30
Last updated
2012-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis, Cholecystolithiasis

Keywords

symptomatic cholecystolithiasis

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.

Interventions

PROCEDUREtransvaginal 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.

Sponsors

Ignazio Tarantino
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* given informed consent for transvaginal hybrid cholecystectomy

Exclusion criteria

* pregnancy * malignoma * present choledocholithiasis

Design outcomes

Primary

MeasureTime frame
Feasibility and safety of the transvaginal operation30 days

Secondary

MeasureTime frame
Long-term life quality and sexual dysfunction3 year

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026