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Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT00961506
Recruitment Status : Completed
First Posted : August 19, 2009
Last Update Posted : August 19, 2009
Sponsor:
Information provided by:
University Hospital, Geneva

Brief Summary:
Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and recovery compare to laparoscopic cholecystectomy.

Condition or disease Intervention/treatment Phase
Gallbladder Disease Procedure: LESS cholecystectomy Procedure: Laparoscopic cholecystectomy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: LESS cholecystectomy
LESS cholecystectomy
Procedure: LESS cholecystectomy
LESS cholecystectomy
Active Comparator: Laparoscopic cholecystectomy
Laparoscopic cholecystectomy
Procedure: Laparoscopic cholecystectomy
laparoscopic cholecystectomy



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

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


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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

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

ClinicalTrials.gov Identifier: NCT00961506     History of Changes
Other Study ID Numbers: CER-08-145a
First Posted: August 19, 2009    Key Record Dates
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