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SILS Cholecystectomy: Cholangiography of the Biliary Tract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056250
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : May 10, 2011
Information provided by:
St John of God Hospital, Vienna

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.

Condition or disease Intervention/treatment Phase
Cholecystolithiasis Procedure: SILS cholangiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Performing Cholangiography During SILS Cholecystectomy: is it Feasible?
Study Start Date : September 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Arm Intervention/treatment
SILS cholangiography
Performing cholangiography in all patients undergoing SILS cholecystectomy.
Procedure: SILS cholangiography
Other Names:
  • LESS

Primary Outcome Measures :
  1. Feasibility of cholangiography during SILS cholecystectomy [ Time Frame: at operation ]

Secondary Outcome Measures :
  1. biliary tract injury [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • cholecystolithiasis

Exclusion Criteria:

  • acute cholecystitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056250

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St John of God Hospital
Vienna, Austria, 1180
Sponsors and Collaborators
St John of God Hospital, Vienna
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Principal Investigator: Bernhard Dauser, MD St John of God Hospital, Vienna
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Responsible Party: Bernhard Dauser, MD, St John of God Hospital, Vienna Identifier: NCT01056250    
Other Study ID Numbers: CT3
SJOG 3 ( Other Identifier: Ethikkommission )
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: July 2010
Keywords provided by St John of God Hospital, Vienna:
Additional relevant MeSH terms:
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Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical