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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gallstone Disease

Intervention / Treatment
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* Procedure: Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with gallstones<br>30 women with symptomatic gallstone disease with an indication for elective cholecystectomy | Procedure: Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no) | Was the introduction of the cholangiography catheter into the cystic duct successfull during transvaginal rigid-hybrid cholecystectomy. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for cholangiography | From incision of the cystic duct to clipping of the cystic duct | intraoperative | 
| Intraoperative complications |  | intraoperative | 
| postoperative complications |  | within 6 weeks from surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transvaginal, NOTES, cholecystectomy, cholangiography, symptomatic gallstone disease