Is Routine Cholecystectomy Reasonable in All Patients Receiving a Bypass Procedure: a Comparative Cohort Study

December 9, 2010 updated by: Cantonal Hospital of St. Gallen
Gallbladder management in bariatric surgery is controversially discussed. While some surgeons advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass (RYGB) others advocate CCE only in patients with pathological gallbladder findings. The aim of this study was to evaluate the necessity of prophylactic CCE in patients receiving a laparoscopic RYGB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

437

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
      • St. Gallen, Switzerland, 9007
        • Department of Surgery

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

Sampling Method

Non-Probability Sample

Study Population

Given indication for laparoscopic Roux-en-Y-gastric bypass

Description

Inclusion Criteria:

  • All patients who received a laparoscopic Roux-en-Y-gastric bypass

Exclusion Criteria:

  • previous CCE
  • open gastric bypass procedure
  • previous bariatric procedure other than gastric banding
  • patients lost to follow up

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
laparoscopic Roux-en-Y-gastric-bypass without cholecystectomy
laparoscopic Roux-en-Y-gastric baypass with cholecystectomy
Procedure: Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
biliary complications resulting from omitted prophylactic cholecystectomy
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
safety of concurrent cholecystectomy
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Cantonal Hospital of St. Gallen

Investigators

  • Principal Investigator: Martin Thurnheer, MD, Cantonal Hospital St. Gallen

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

December 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 12, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 9, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • EKSG10/140/U

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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