Is Routine Cholecystectomy Reasonable in All Patients Rec... | NCT01219166

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

NCT01219166

Sponsor

Cantonal Hospital of St. Gallen

Status

Completed

Last Update Posted

Dec 10, 2010Estimated

Enrollment

437Estimated

Phase

Not provided

Conditions

Given Indication for Gastric Bypass Procedure

Interventions

Laparoscopic Cholecystectomy

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Oct 12, 2010

First Submission Date that Met QC Criteria

Oct 12, 2010

First Posted Date

Oct 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2010

Last Update Posted Date

Dec 10, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

437Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laparoscopic Roux-en-Y-gastric-bypass without cholecystectomy
laparoscopic Roux-en-Y-gastric baypass with cholecystectomy			Procedure: Laparoscopic Cholecystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic Cholecystectomy	Procedure	Laparoscopic Cholecystectomy	laparoscopic Roux-en-Y-gastric baypass with cholecystectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
safety of concurrent cholecystectomy		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Thurnheer, MD	Cantonal Hospital of St. Gallen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of surgery		Sankt Gallen		9007	Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
D017081	Cholecystectomy, Laparoscopic

Ancestor Terms

ID	Term
D002763	Cholecystectomy
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided