A Randomized Trial of Ostomy Closure Techniques

A Randomized Trial of Ostomy Closure Techniques: An Outcomes Evaluation of Primary Closure Versus Pursestring Closure

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.

Study Overview

• Status: Completed
• Conditions: Wound Infection
• Intervention / Treatment: Procedure: Purse string closure; Procedure: Primary closure

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Purse string closure; Patients undergo a purse string closure of their old stoma site.	Procedure: Purse string closure; 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.; 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.; Diameter of the skin defect should then be measured.; A postoperative photo will then be taken.
Active Comparator: Primary closure; Patients have their stoma sites close primarily with staples.	Procedure: Primary closure; 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.; 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.; Length of the incision should be measured in centimeters.; A postoperative photo will then be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
surgical site infection	30 days postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Centre Hospitalier Universitaire Vaudois

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 22, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimate): October 24, 2012

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: ileostomy; surgical site infection; Surgical Stomas
• Additional Relevant MeSH Terms: Infections; Wound Infection
• Other Study ID Numbers: 0806M37362