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

This study has been completed.
Sponsor:
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01219166
First received: October 12, 2010
Last updated: December 9, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Given Indication for Gastric Bypass Procedure
 Procedure: Laparoscopic Cholecystectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • biliary complications resulting from omitted prophylactic cholecystectomy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety of concurrent cholecystectomy [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 437
Study Start Date: December 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
laparoscopic Roux-en-Y-gastric-bypass without cholecystectomy
laparoscopic Roux-en-Y-gastric baypass with cholecystectomy Procedure: Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219166

Locations
Switzerland
Department of surgery
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Martin Thurnheer, MD Cantonal Hospital St. Gallen
  More Information

No publications provided

Responsible Party: Andreas Zerz, MD, Kantonal Hospital St. Gallen, Department of Visceral Surgery
ClinicalTrials.gov Identifier: NCT01219166     History of Changes
Other Study ID Numbers: EKSG10/140/U
Study First Received: October 12, 2010
Last Updated: December 9, 2010
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on May 16, 2013