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:


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
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: 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 September 22, 2014