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Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00961506
First Posted: August 19, 2009
Last Update Posted: August 19, 2009
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:
University Hospital, Geneva
  Purpose
Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and recovery compare to laparoscopic cholecystectomy.

Condition Intervention Phase
Gallbladder Disease Procedure: LESS cholecystectomy Procedure: Laparoscopic cholecystectomy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Body image scale [ Time Frame: 1 months ]

Secondary Outcome Measures:
  • pain VAS [ Time Frame: 10 days ]
  • Analgesic requirement
  • time to return to work
  • scar scale [ Time Frame: 1 months ]

Enrollment: 40
Study Start Date: March 2009
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LESS cholecystectomy
LESS cholecystectomy
Procedure: LESS cholecystectomy
LESS cholecystectomy
Active Comparator: Laparoscopic cholecystectomy
Laparoscopic cholecystectomy
Procedure: Laparoscopic cholecystectomy
laparoscopic cholecystectomy

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • gallbladder disease Age: 18-99

Exclusion Criteria:

  • intolerance to laparoscopy
  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): NCT00961506


Locations
Switzerland
University Hospital Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Pascal Bucher, MD University Hospital, Geneva
  More Information

ClinicalTrials.gov Identifier: NCT00961506     History of Changes
Other Study ID Numbers: CER-08-145a
First Submitted: August 18, 2009
First Posted: August 19, 2009
Last Update Posted: August 19, 2009
Last Verified: August 2009

Keywords provided by University Hospital, Geneva:
cholecystectomy
gallbladder
laparoscopy
laparoendoscopic

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases