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NCT00964379 Clinical Trial

Intraperitoneal Versus Extraperitoneal Colostomy

Colostomy Clinical Trial

Official title:
Prospective Randomized Trial of Intraperitoneal Versus Extraperitoneal Techniques for Construction of Terminal Iliac Fossa Colostomies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00964379
Other study ID # 528-93
Secondary ID
Status Completed
Phase Phase 3
First received August 11, 2009
Last updated November 11, 2013
Start date January 1988
Est. completion date June 2013

Study information
Verified date November 2013
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- permanent colostomy

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• intraperitoneal or extraperitoneal colostomy
creation of colostomy

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary parastomal hernia, stoma dysfunction 7 years No
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