Text Size

Intraperitoneal Versus Extraperitoneal Colostomy

This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00964379
First received: August 11, 2009
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  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 ]

Estimated Enrollment: 200
Study Start Date: January 1988
Estimated Study Completion Date: June 2013
Estimated 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

Contacts
Contact: Bruce G Wolff, MD 800-533-1564 wolff.bruce@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Bruce Wolff, MD     800-533-1564     wolff.bruce@mayo.edu    
Principal Investigator: Bruce G Wolff, MD            
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: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Intra versus extraperitoneal colostomy

ClinicalTrials.gov processed this record on May 23, 2013