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Intraperitoneal Versus Extraperitoneal Colostomy

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ClinicalTrials.gov Identifier: NCT00964379
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : November 13, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
This is a prospective randomized trial of intraperitoneal versus extraperitoneal techniques for construction of terminal iliac fossa colostomies.

Condition or disease Intervention/treatment Phase
Colostomy Procedure: intraperitoneal or extraperitoneal colostomy Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
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
Study Start Date : January 1988
Primary Completion Date : June 2013
Study Completion Date : June 2013
Arms and Interventions

Arm Intervention/treatment
Active Comparator: intraperitoneal colostomy Procedure: intraperitoneal or extraperitoneal colostomy
creation of colostomy
Active Comparator: extraperitoneal colostomy Procedure: intraperitoneal or extraperitoneal colostomy
creation of colostomy


Outcome Measures

Primary Outcome Measures :
  1. parastomal hernia, stoma dysfunction [ Time Frame: 7 years ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: August 24, 2009    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Mayo Clinic:
Intra versus extraperitoneal colostomy