Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

August 18, 2009 updated by: University Hospital, Geneva
Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and recovery compare to laparoscopic cholecystectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • University Hospital Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • gallbladder disease Age: 18-99

Exclusion Criteria:

  • intolerance to laparoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LESS cholecystectomy
Procedure: LESS cholecystectomy
LESS cholecystectomy
Active Comparator: Laparoscopic cholecystectomy
Procedure: Laparoscopic cholecystectomy
laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body image scale
Time Frame: 1 months
1 months

Secondary Outcome Measures

Outcome Measure
Time Frame
pain VAS
Time Frame: 10 days
10 days
Analgesic requirement
time to return to work
scar scale
Time Frame: 1 months
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Pascal Bucher, MD, University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

August 18, 2009

First Submitted That Met QC Criteria

August 18, 2009

First Posted (Estimate)

August 19, 2009

Study Record Updates

Last Update Posted (Estimate)

August 19, 2009

Last Update Submitted That Met QC Criteria

August 18, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER-08-145a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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