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SILS Cholecystectomy: Cholangiography of the Biliary Tract

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056250
First Posted: January 26, 2010
Last Update Posted: May 10, 2011
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.
Information provided by:
St John of God Hospital, Vienna
  Purpose
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 Intervention
Cholecystolithiasis Procedure: SILS cholangiography

Study Type: Interventional
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by St John of God Hospital, Vienna:

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

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

Estimated Enrollment: 20
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SILS cholangiography
Performing cholangiography in all patients undergoing SILS cholecystectomy.
Procedure: SILS cholangiography
intraoperative
Other Names:
  • LESS
  • E-NOTES

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: January 24, 2010
First Posted: January 26, 2010
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