RecruitingACTRN12618000542291

Stoma closure using bio-absorbable reinforcement (SCUBAR).

Prevention of incisional hernia after stoma closure using a synthetic bio-absorbable tissue reinforcement.

Sponsor

Westmead Hospital

Enrollment

288 participants

Start Date

Dec 10, 2018

Study Type

Interventional

Conditions

Incisional hernia after stoma reversal or resiting

Summary

The rate of incisional hernia formation following closure of a temporary intestinal stoma is approximately 30%. Hernias following abdominal surgery are a significant cause of morbidity and may adversely affect a patient's quality of life and may require emergent repair. Currently closure of the abdominal fascia is accomplished with sutures however, newer surgical materials are now available to reinforce fascial closure which have shown promise in their abilities to reduce IH formation and tolerate bacterial contamination that is present in these contaminated wounds. We propose a randomised clinical trial in patients undergoing reversal or resiting of an intestinal stoma to have placement of a new synthetic tissue reinforcement material or standard repair to determine if this material can reduce incisional hernia formation with low morbidity, specifically surgical site infection which has prohibited the use of existing materials.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether placing a new type of absorbable mesh reinforcement at the site where a temporary bowel opening (stoma) is reversed reduces the risk of a hernia forming in the scar. After stoma reversal surgery, approximately 30% of patients develop a hernia — a weakness in the abdominal wall that can cause discomfort, require further surgery, and significantly affect quality of life. Existing mesh materials often can't be used in these surgeries because of infection risk, but a new bio-absorbable material may solve this problem. Adults having elective ileostomy or colostomy reversal will be randomly assigned to receive either the new absorbable mesh reinforcement or standard suture closure. They will be followed up for 3 years to check whether a hernia develops. You may be eligible if you are over 18, are scheduled for elective stoma reversal or re-siting surgery, and are willing to attend follow-up appointments over 3 years. Pregnant women and people who already have non-absorbable mesh at the stoma site are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention: At the time of stoma reversal or resiting, the intervention group will have Gore BioA synthetic absorbable tissue reinforcement placed by the operating surgeon in either the pre-peritoneal (retro-rectus) space or deep to the anterior fascia of the abdominal wall at the site of the stoma reversal. The recto-rectus position is preferred. If Gore BioA is to be placed in the retro-rectus position, after developing the pre-peritoneal space, the peritoneum will be closed with 2-0 or 3-0 PGA sutures at the discretion of the surgeon. Ideally the space created should be adequate to place the Gore™ BioA™ FS0808 (8 x 8cm). The Gore BioA is to be secured with 4 x 3-0 polydioxanone sutures. Suture closure of the fascia will be performed with interrupted 0 polydioxanone sutures. The additional time required to place and secure the mesh is estimated to be 10 minutes.

Locations(5)

Westmead Hospital - Westmead

NSW, Australia

Westmead Private Hospital - Westmead

NSW, Australia

Blacktown Hospital - Blacktown

NSW, Australia

Mount Druitt Hospital - Mount Druitt

NSW, Australia

Norwest Private Hospital - Bella Vista

NSW, Australia

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ACTRN12618000542291