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Intraperitoneal Versus Extraperitoneal Colostomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00964379
First Posted: August 24, 2009
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • permanent colostomy

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964379


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

Responsible Party: Bruce G. Wolff, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00964379     History of Changes
Other Study ID Numbers: 528-93
First Submitted: August 11, 2009
First Posted: August 24, 2009
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Mayo Clinic:
Intra versus extraperitoneal colostomy