3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 8 sources, which was discussed by the committee. The evidence included 2 systematic reviews and meta-analyses, 3 randomised controlled trials, 2 non-randomised comparative studies and 1 case series, and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: occurrence of symptomatic parastomal hernia and quality of life.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: need for reoperation, infection, synthetic or biological mesh-associated complications, fistulation, bowel obstruction and bowel adhesion.
3.4 Ten commentaries from patients who had experience of this procedure were received, which were discussed by the committee.
3.5 The committee noted that there are different types of synthetic or biological meshes (some from animal origin) and various techniques for constructing stomas. This makes the evidence difficult to assess.
3.6 The committee noted that most of the evidence comes from colostomy procedures.
3.7 Synthetic or biological mesh is difficult to remove should this be needed, and it is more difficult to repair a parastomal hernia if a mesh is already in place.
3.8 The committee was informed that there is little evidence to support the use of this procedure for colostomies in patients with inflammatory bowel disease, and that there is a risk of further serious complications in these patients.
3.9 Synthetic or biological mesh-associated complications may include fistulation and infection.