A Randomized Trial of Ostomy Closure Techniques

University of Minnesota (UMN)

Status: Completed

Conditions: Wound Infection

Treatments: Procedure: Primary closure; Procedure: Purse string closure

Study type: Interventional

Funder types: Other

Identifiers

NCT01713452

0806M37362

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

Purse string closure

Active Comparator group

Description:

Patients undergo a purse string closure of their old stoma site.

Treatment:

Procedure: Purse string closure

Primary closure

Active Comparator group

Description:

Patients have their stoma sites close primarily with staples.

Treatment:

Procedure: Primary closure