Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

SILS Cholecystectomy: Cholangiography of the Biliary Tract

This study has been completed.
Sponsor:
Information provided by:
St John of God Hospital, Vienna
ClinicalTrials.gov Identifier:
NCT01056250
First received: January 24, 2010
Last updated: May 8, 2011
Last verified: July 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • biliary tract injury [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cholecystolithiasis

Exclusion Criteria:

  • acute cholecystitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 24, 2010
Last Updated: May 8, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by St John of God Hospital, Vienna:
cholelithiasis

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

ClinicalTrials.gov processed this record on November 24, 2014