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

An Open Case Series About Technical Feasibility of Routine Intraoperative Cholangiography (IOC) During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy (tvNCC)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01583348
Enrollment
33
Registered
2012-04-24
Start date
2012-04-30
Completion date
2013-04-30
Last updated
2013-04-30

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

Conditions

Gallstone Disease

Keywords

transvaginal, NOTES, cholecystectomy, cholangiography, symptomatic gallstone disease

Brief summary

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.

Interventions

PROCEDURECholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy

During transvaginal rigid-hybrid NOTES cholecystectomy a intraoperative cholangiography is performed. After dissection of the Calot's triangle and distal clipping of the cystic duct, the cystic duct is incised and a regular cholangiography catheter is inserted. Contrast is injected and an image is obtained using an image-converter. After extraction of the catheter the cystic duct is clipped proximally. This intervention is performed in all patients included in the study.

Sponsors

Cantonal Hosptal, Baselland
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no)intraoperativeWas the introduction of the cholangiography catheter into the cystic duct successfull during transvaginal rigid-hybrid cholecystectomy.

Secondary

MeasureTime frameDescription
Time required for cholangiographyintraoperativeFrom incision of the cystic duct to clipping of the cystic duct
Intraoperative complicationsintraoperative
postoperative complicationswithin 6 weeks from surgery

Countries

Switzerland

Outcome results

None listed

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