Stoma closure using bio-absorbable reinforcement (SCUBAR).
Prevention of incisional hernia after stoma closure using a synthetic bio-absorbable tissue reinforcement.
Westmead Hospital
288 participants
Dec 10, 2018
Interventional
Conditions
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
Inclusion Criteria5
- Patient population: Any adult patients presenting for elective ileostomy or colostomy closure or re-siting.
- Age > 18 years
- Patient with a temporary stoma that has met criteria for stoma reversal or a permanent or temporary stoma that requires resiting.
- Patient capable of participating in informed consent for the study
- Patient willing to complete follow-up over the study period (3 years).
Exclusion Criteria2
- Pregnancy
- Pre-existing placement of synthetic non-absorbable mesh in the region of the stoma site.
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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)
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ACTRN12618000542291