Back to resultsSILS Cholecystectomy: Cholangiography of the Biliary Tract
Primary Purpose
Cholecystolithiasis
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
SILS cholangiography
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystolithiasis focused on measuring cholelithiasis
Eligibility Criteria
Inclusion Criteria:
- cholecystolithiasis
Exclusion Criteria:
- acute cholecystitis
Sites / Locations
- St John of God Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SILS cholangiography
Arm Description
Performing cholangiography in all patients undergoing SILS cholecystectomy.
Outcomes
Primary Outcome Measures
Feasibility of cholangiography during SILS cholecystectomy
Secondary Outcome Measures
biliary tract injury
Full Information
NCT ID
NCT01056250
First Posted
January 24, 2010
Last Updated
May 8, 2011
Sponsor
St John of God Hospital, Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01056250
Brief Title
SILS Cholecystectomy: Cholangiography of the Biliary Tract
Official Title
Performing Cholangiography During SILS Cholecystectomy: is it Feasible?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
St John of God Hospital, Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis
Keywords
cholelithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SILS cholangiography
Arm Type
Other
Arm Description
Performing cholangiography in all patients undergoing SILS cholecystectomy.
Intervention Type
Procedure
Intervention Name(s)
SILS cholangiography
Other Intervention Name(s)
LESS, E-NOTES
Intervention Description
intraoperative
Primary Outcome Measure Information:
Title
Feasibility of cholangiography during SILS cholecystectomy
Time Frame
at operation
Secondary Outcome Measure Information:
Title
biliary tract injury
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cholecystolithiasis
Exclusion Criteria:
acute cholecystitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard Dauser, MD
Organizational Affiliation
St John of God Hospital, Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
St John of God Hospital
City
Vienna
ZIP/Postal Code
1180
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
SILS Cholecystectomy: Cholangiography of the Biliary Tract
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