Guidance
1 Recommendations
1 Recommendations
1.1 The evidence on the safety of reinforcement of a permanent stoma with a synthetic or biological mesh to prevent a parastomal hernia shows there are serious but well-recognised complications. The evidence on efficacy is limited in quantity and quality. Therefore, this procedure should not be used unless special arrangements are in place for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.
1.2 Clinicians wishing to do reinforcement of a permanent stoma with a synthetic or biological mesh to prevent a parastomal hernia should:
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Inform the clinical governance leads in their NHS trusts.
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Ensure that patients understand the procedure's safety and efficacy, as well as any uncertainties about these. Provide them with clear written information to support shared decision making. In addition, the use of NICE's information for the public is recommended.
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Audit and review clinical outcomes of all patients having the procedure. NICE has identified relevant audit criteria and has developed an audit tool (which is for use at local discretion).
1.3 All adverse events involving the medical devices (including the synthetic or biological mesh) used in this procedure should be reported to the Medicines and Healthcare products Regulatory Agency.
1.4 Further research could be in the form of randomised controlled trials, observational studies and analysis of registry data. It should report details of patient selection, the type of synthetic or biological mesh used, mesh-associated complications and long-term outcomes (at least 3 years). In participating centres, clinicians should encourage patients to take part in the National Institute for Health Research CIPHER study.