Intraperitoneal Versus Extraperitoneal Colostomy

Phase 3

Completed

• Conditions: Colostomy
• Interventions: Procedure: intraperitoneal or extraperitoneal colostomy

• Registration Number: NCT00964379
• Lead Sponsor: Mayo Clinic

Brief Summary

This is a prospective randomized trial of intraperitoneal versus extraperitoneal techniques for construction of terminal iliac fossa colostomies.

Detailed Description

Not available

Study Timeline

• Study Start: 1988-01
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-24
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• permanent colostomy

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intraperitoneal colostomy	intraperitoneal or extraperitoneal colostomy	-
extraperitoneal colostomy	intraperitoneal or extraperitoneal colostomy	-

Primary Outcome Measures

Name	Time	Method
parastomal hernia, stoma dysfunction	7 years

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States