Gallstone Disease Clinical Trial
Official title:
An Open Case Series About Technical Feasibility of Routine Intraoperative Cholangiography (IOC) During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy (tvNCC)
Verified date | April 2013 |
Source | Cantonal Hosptal, Baselland |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Observational |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | April 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | Cantonal Hospital Baselland, Bruderholz, Department of Surgery | Bruderholz | Baselland |
Lead Sponsor | Collaborator |
---|---|
Cantonal Hosptal, Baselland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Time required for cholangiography | From incision of the cystic duct to clipping of the cystic duct | intraoperative | No |
Secondary | Intraoperative complications | intraoperative | Yes | |
Secondary | postoperative complications | within 6 weeks from surgery | Yes |
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