1.1 Current evidence on the safety and efficacy of insertion of a collagen plug to close an abdominal wall enterocutaneous fistula is inadequate in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to insert a collagen plug to close an abdominal wall enterocutaneous fistula should take the following actions.
Inform the clinical governance leads in their NHS trust.
Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, the use of NICE's information for the public is recommended.
1.3 NICE encourages further research into insertion of a collagen plug to close an abdominal wall enterocutaneous fistula. Research should ideally take the form of prospective studies that compare the course of the enterocutaneous fistula (its natural history) with and without use of the procedure. Reports should record the conditions underlying all fistulas that are treated, their location, whether they are high or low output, and details of previous treatments. NICE may update the guidance on publication of further evidence.