NCT01219166

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
437

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 10, 2010

Status Verified

October 1, 2010

Enrollment Period

Same day

First QC Date

October 12, 2010

Last Update Submit

December 9, 2010

Conditions

Given Indication for Gastric Bypass Procedure

Outcome Measures

Primary Outcomes (1)

  • biliary complications resulting from omitted prophylactic cholecystectomy

    5 years

Secondary Outcomes (1)

  • safety of concurrent cholecystectomy

    30 days

Study Arms (2)

laparoscopic Roux-en-Y-gastric-bypass without cholecystectomy

laparoscopic Roux-en-Y-gastric baypass with cholecystectomy

Procedure: Laparoscopic Cholecystectomy

Interventions

Laparoscopic CholecystectomyPROCEDURE

Laparoscopic Cholecystectomy

laparoscopic Roux-en-Y-gastric baypass with cholecystectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of surgery

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Martin Thurnheer, MD

    Cantonal Hospital of St. Gallen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 13, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 10, 2010

Record last verified: 2010-10

Locations

CH(1)