A Randomized Trial of Ostomy Closure Techniques

NCT ID: NCT01713452

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-10-31

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.

Conditions

Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Purse string closure

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

Group Type: ACTIVE_COMPARATOR

Purse string closure

Intervention Type: PROCEDURE

1. An incision around the stoma will be made with 2-3 mm circumferential margins. This dissection along the mucocutaneous junction will then be made to the fascial defect. Re-establishment of bowel continuity will them be performed. If the circumferential incision does not provide adequate exposure, the incision can be converted to an elliptical one. Thereafter, it will be closed primarily with staples, similar to the primary closure group.

2. Following ostomy closure, the subcutaneous tissues will be irrigated. A 2-0 monocryl subcuticular purse string stitch will then be placed and cinched to a 1cm diameter. This opening will then be packed with Nu-Gauze as a wick dressing.

3. Diameter of the skin defect should then be measured.

4. A postoperative photo will then be taken.

Primary closure

Patients have their stoma sites close primarily with staples.

Group Type: ACTIVE_COMPARATOR

Primary closure

Intervention Type: PROCEDURE

1. An elliptical incision (extending transversely) will be made with 2-3 mm superior/inferior margins around the mucocutaneous junction. Dissection will then be made in a perpendicular fashion through the subcutaneous tissue with tapering near the fascial defect. Re-establishment of bowel continuity will then be performed.

2. Following ostomy closure, the subcutaneous tissue will be irrigated and the skin will be closed tight with staples placed at close intervals (<1.5cm). No subcutaneous drains will be placed.

3. Length of the incision should be measured in centimeters.

4. A postoperative photo will then be taken.

Interventions

Purse string closure

1. An incision around the stoma will be made with 2-3 mm circumferential margins. This dissection along the mucocutaneous junction will then be made to the fascial defect. Re-establishment of bowel continuity will them be performed. If the circumferential incision does not provide adequate exposure, the incision can be converted to an elliptical one. Thereafter, it will be closed primarily with staples, similar to the primary closure group.

2. Following ostomy closure, the subcutaneous tissues will be irrigated. A 2-0 monocryl subcuticular purse string stitch will then be placed and cinched to a 1cm diameter. This opening will then be packed with Nu-Gauze as a wick dressing.

3. Diameter of the skin defect should then be measured.

4. A postoperative photo will then be taken.

Intervention Type: PROCEDURE

Primary closure

1. An elliptical incision (extending transversely) will be made with 2-3 mm superior/inferior margins around the mucocutaneous junction. Dissection will then be made in a perpendicular fashion through the subcutaneous tissue with tapering near the fascial defect. Re-establishment of bowel continuity will then be performed.

2. Following ostomy closure, the subcutaneous tissue will be irrigated and the skin will be closed tight with staples placed at close intervals (<1.5cm). No subcutaneous drains will be placed.

3. Length of the incision should be measured in centimeters.

4. A postoperative photo will then be taken.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

Lee JT, Marquez TT, Clerc D, Gie O, Demartines N, Madoff RD, Rothenberger DA, Christoforidis D. Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial. Dis Colon Rectum. 2014 Nov;57(11):1282-9. doi: 10.1097/DCR.0000000000000209.

Reference Type: DERIVED

PMID: 25285695 (View on PubMed)

Other Identifiers

0806M37362

Identifier Type: -

Identifier Source: org_study_id