Technical Feasibility of Routine Intraoperative Cholangiography During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy

Cantonal Hosptal, Baselland

Status: Completed

Conditions: Gallstone Disease

Treatments: Procedure: Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT01583348

45/12

Details and patient eligibility

About

While gold standard in the treatment of symptomatic gall stones is laparoscopic cholecystectomy with instruments introduced through multiple abdominal wall incisions, transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective and safe. However it has not been demonstrated up-to-date if intraoperative cholangiography is feasible during such procedure. This observational case series describes success and technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy. The investigators hypothesis is that cholangiography is feasible equal to conventional laparoscopic cholecystectomy.

Enrollment: 33 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• symptomatic gallstone disease
• age > 18 years
• written informed consent

Exclusion criteria

• age < 18 years
• not able to understand informed consent
• pregnancy
• vaginal atresia
• florid vaginal infection
• gynecological neoplasia
• allergy to Iod
• missing informed consents
• emergency procedure

Trial design

33 participants in 1 patient group

Women with gallstones

Description:

30 women with symptomatic gallstone disease with an indication for elective cholecystectomy

Treatment:

Procedure: Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy