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Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

This study has been completed.
Information provided by:
University Hospital, Geneva Identifier:
First received: August 18, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain VAS [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Analgesic requirement [ Designated as safety issue: No ]
  • time to return to work [ Designated as safety issue: No ]
  • scar scale [ Time Frame: 1 months ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • gallbladder disease Age: 18-99

Exclusion Criteria:

  • intolerance to laparoscopy
  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 identifier: NCT00961506

University Hospital Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Principal Investigator: Pascal Bucher, MD University Hospital, Geneva
  More Information Identifier: NCT00961506     History of Changes
Other Study ID Numbers: CER-08-145a 
Study First Received: August 18, 2009
Last Updated: August 18, 2009
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Geneva:

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases processed this record on December 08, 2016