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SILS Cholecystectomy: Cholangiography of the Biliary Tract

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ClinicalTrials.gov Identifier: NCT01056250
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : May 10, 2011
Sponsor:
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

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
U.S. FDA Resources

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



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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT01056250


Locations
Austria
St John of God Hospital
Vienna, Austria, 1180
Sponsors and Collaborators
St John of God Hospital, Vienna
Investigators
Principal Investigator: Bernhard Dauser, MD St John of God Hospital, Vienna

Responsible Party: Bernhard Dauser, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier: NCT01056250     History of Changes
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:
cholelithiasis

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical