None listed
Conditions
Brief summary
Parastomal hernias represent a significant morbidity for patients who require permanent stomas. Furthermore, they occur in up to 50-80% of these patients, resulting in a significant societal burden. The use of mesh is now standard surgical practice for the repair of all types of hernias, including parastomal hernias. However, repairing parastomal hernias can be very complex, and often carry their own complications such as enterotomies, prolonged ileus, recurrence, mesh infections, and fistula formation. As such, given the high rate of parastomal hernias, there has been increasing interest in using mesh at the time of stoma formation to prevent this complication. Biologic mesh represents a promising solution to this problem. Biologic mesh has been shown to be an effective tool in hernia repair, without the infection and erosion complications associated with synthetic permanent meshes. A single initial study has been promising, demonstrating similarly low hernia rates as with synthetic meshes. However, questions still remain about whether the added costs associated with expensive biologic meshes can be offset by these potential reductions in patient morbidity. This primary aim of this study is to determine the effectiveness of using biologic mesh at the time of formation of a permanent stoma in the prevention of parastomal hernias. The hypothesis is that the Surgisis (Registered Trademark) biologic mesh will reduce rates of parastomal hernia in patients. Secondary aims of this study include the assessment of any complications arising from this technique, as well as to assess the cost effectiveness of using biologic mesh over the study period.
Interventions
Intervention arm: Surgisis (Registered Trademark) biologic mesh provided by Cook Biotech (Registered Trademark) will be inserted at the time of stoma formation. It is not routine to insert mesh around the stoma. Mesh is used to repair parastomal hernias when they occur. This trial is to test whether prophylactic mesh at the time of stoma formation reduces the incidence of parastomal hernia. The intervention arm will undergo the insertion of biologic mesh placed intra-peritoneally around the stoma. The estimated extra time required to fixate the mesh around the stoma site would be approximately fifteen minutes. Aside from the procedure of a biologic mesh insertion, all patients in both the control and experimental groups will undergo the same preparation, care, and follow-up post surgery.
Sponsors
Study design
Eligibility
Inclusion criteria
Age 18 years or older; undergoing colostomy, ileostomy, or ileal or colonic conduits; Patients fit for surgery; Informed consent attained.
Exclusion criteria
Age less than 18 years; patients who have previously had mesh inserted to the site of stoma formation or those who cannot have mesh inserted; no informed consent.