Skip to content

A randomized control trial evaluating the effects of biologic mesh for the prevention of parastomal hernias in patients undergoing colostomy, ileostomy, ileal, colonic or conduits.

A randomised controlled trial evaluating the effects of biologic mesh for the prevention of parastomal hernias in patients undergoing colostomy, ileostomy, ileal, colonic or conduits

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000221651
Acronym
RCT MESH STUDY
Enrollment
76
Registered
2014-03-03
Start date
2014-04-01
Completion date
2015-03-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

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

Dr. Peter Lee
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026