Intraperitoneal Versus Extraperitoneal Colostomy

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00964379
First received: August 11, 2009
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Colostomy
Procedure: intraperitoneal or extraperitoneal colostomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Intraperitoneal Versus Extraperitoneal Techniques for Construction of Terminal Iliac Fossa Colostomies

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • parastomal hernia, stoma dysfunction [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: January 1988
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intraperitoneal colostomy Procedure: intraperitoneal or extraperitoneal colostomy
creation of colostomy
Active Comparator: extraperitoneal colostomy Procedure: intraperitoneal or extraperitoneal colostomy
creation of colostomy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • permanent colostomy

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964379

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Bruce G. Wolff, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00964379     History of Changes
Other Study ID Numbers: 528-93
Study First Received: August 11, 2009
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Intra versus extraperitoneal colostomy

ClinicalTrials.gov processed this record on April 17, 2014