None listed
Conditions
Brief 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.
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
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.
Sponsors
Westmead Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient population: Any adult patients presenting for elective ileostomy or colostomy closure or re-siting. Inclusion criteria: 1. Age > 18 years 2. Patient with a temporary stoma that has met criteria for stoma reversal or a permanent or temporary stoma that requires resiting. 3. Patient capable of participating in informed consent for the study 4. Patient willing to complete follow-up over the study period (3 years).
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Pre-existing placement of synthetic non-absorbable mesh in the region of the stoma site.
Outcome results
None listed