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NCT01056250 Clinical Trial

SILS Cholecystectomy: Cholangiography of the Biliary Tract

Cholecystolithiasis Clinical Trial

Official title:
Performing Cholangiography During SILS Cholecystectomy: is it Feasible?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01056250
Other study ID # CT3
Secondary ID SJOG 3
Status Completed
Phase N/A
First received January 24, 2010
Last updated May 8, 2011
Start date September 2009
Est. completion date December 2010

Study information
Verified date July 2010
Source St John of God Hospital, Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial Summary

Single Incision Laparoscopic Surgery (SILS) can be performed for different standard operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to identify and preserve relevant structures. The investigators want to evaluate feasibility of performing cholangiography during SILS cholecystectomy.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- cholecystolithiasis

Exclusion Criteria:

- acute cholecystitis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• SILS cholangiography
intraoperative

Locations
Country Name City State
Austria St John of God Hospital Vienna

Sponsors (1)
Lead Sponsor Collaborator
St John of God Hospital, Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of cholangiography during SILS cholecystectomy at operation Yes
Secondary biliary tract injury 2 weeks Yes
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