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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 02, 2014