A Randomized Trial of Ostomy Closure Techniques

Not Applicable

Completed

• Conditions: Wound Infection
• Interventions: Procedure: Purse string closure; Procedure: Primary closure

• Registration Number: NCT01713452
• Lead Sponsor: University of Minnesota

Brief Summary

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 clean-contaminated operative classification. The ideal stoma site closure technique is still debated in the current literature. The aim of this study was to compare the rate of SSI following two different stoma closure techniques, primary closure versus a skin approximating purse string closure, in a multi-center randomized controlled trial. The investigators hypothesize that purse string closure technique will have a lower rate of SSI than primary closure technique.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2012-08
• Study Completion: 2012-10
• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-24
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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)

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Purse string closure	Purse string closure	Patients undergo a purse string closure of their old stoma site.
Primary closure	Primary closure	Patients have their stoma sites close primarily with staples.

Primary Outcome Measures

Name	Time	Method
surgical site infection	30 days postoperatively

Secondary Outcome Measures

Name	Time	Method
delayed wound healing	30 days postoperatively	Evidence of delayed wound-healing at stoma takedown site
patient satisfaction	30 days postoperatively	We are measuring subject satisfaction with wound healing and cosmetic outcome

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States