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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01583348
Other study ID # 45/12
Secondary ID
Status Completed
Phase N/A
First received April 20, 2012
Last updated April 28, 2013
Start date April 2012
Est. completion date April 2013

Study information

Verified date April 2013
Source Cantonal Hosptal, Baselland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Procedure:
Cholangiography 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.

Locations

Country Name City State
Switzerland Cantonal Hospital Baselland, Bruderholz, Department of Surgery Bruderholz Baselland

Sponsors (1)

Lead Sponsor Collaborator
Cantonal Hosptal, Baselland

Country where clinical trial is conducted

Switzerland, 

Outcome

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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