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COMPLETEDNANCT01713452

A Randomized Trial of Ostomy Closure Techniques

Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than expected for a clea...

Lead sponsor: University of Minnesota•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Minnesota

Collaborators

Centre Hospitalier Universitaire Vaudois

The investigators will randomize ileostomy takedown patients to either a primary closure or purse string closure technique intraoperatively. Surgeons at both the University of Minnesota and the CHUV hospital in Switzerland will participate in the this study.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Subjects eligible are those with either a colostomy or ileostomy (end or loop) who are deemed by their surgeon to be appropriate candidates for ostomy closure. There will be no limitations based upon initial indication for formation of the ostomy. Indications for initial ostomy formation for fecal diversion can include: infection (e.g. diverticulitis) and protection of an anastomosis. (following resection for inflammatory bowel disease, benign diseases, or cancer)

Exclusion Criteria

•Subjects will be excluded from the study if:
•1. The stoma site is left open to heal by secondary intention due to gross contamination (surgeon discretion)
•2. The stoma site is re-used (i.e. the same stoma site used for the formation of a new ostomy)
•3. A new stoma is created at a different site.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 1, 2019Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment125

Start dateDec 2008

Last updatedNov 1, 2019

Condition

Wound Infection

Locations shown

University of Minnesota

Minneapolis, Minnesota

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2019Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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