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Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00961506
First received: August 18, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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
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

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gallbladder disease Age: 18-99

Exclusion Criteria:

  • intolerance to laparoscopy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
cholecystectomy
gallbladder
laparoscopy
laparoendoscopic

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

ClinicalTrials.gov processed this record on June 18, 2013