Intraperitoneal Versus Extraperitoneal Colostomy

NCT00964379 — Phase 3, Completed, 81 participants, Mayo Clinic
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Prospective Randomized Trial of Intraperitoneal Versus Extraperitoneal Techniques for Construction of Terminal Iliac Fossa Colostomies

RegistryNCT00964379
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment81 (Actual)
SponsorMayo Clinic (Other)
ConditionsColostomy
Interventionsintraperitoneal or extraperitoneal colostomy (Procedure)
Datesstart 1988-01-01, primary completion 2013-06-01, completion 2013-06-01, first posted 2009-08-24, last updated 2013-11-13
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Colostomy All trials of intraperitoneal or extraperitoneal colostomy

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
intraperitoneal colostomyActive comparatorProcedure: intraperitoneal or extraperitoneal colostomy
extraperitoneal colostomyActive comparatorProcedure: intraperitoneal or extraperitoneal colostomy
  • intraperitoneal or extraperitoneal colostomy (Procedure): creation of colostomy

+Outcome measures

Primary outcomes

  • parastomal hernia, stoma dysfunction [7 years]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* permanent colostomy

Exclusion Criteria:

* none

+Locations (1)

FacilityCityCountryStatus
Mayo ClinicRochester, MinnesotaUnited States