The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Insertion of a collagen plug to close an abdominal wall enterocutaneous fistula, in December 2014.
A variety of techniques have been described for insertion of a collagen plug to close an enterocutaneous fistula, most being carried out with the patient under sedation. The fistula track is visualised using fluoroscopy and may need dilatation to allow passage of the plug. The track is then debrided to improve incorporation of the plug. A guide wire is inserted from the skin surface through the track into the bowel lumen and a delivery sheath is put in place. Once the delivery sheath is in position, the collagen plug is passed through the track, under fluoroscopic guidance. The delivery sheath is then taken out. The collagen plug is secured in place with absorbable sutures and a Molnar disc (a disc which lies against the skin at the external opening of the fistula, to help keep the device in place). A radiopaque flange (footplate) attached to the internal end of the plug creates a seal to help stop enteric fluids from entering the fistula track, and allows visualisation of the plug during placement. The collagen plug fills the fistula track and acts as a scaffold for tissue growth, allowing the fistula to become filled with tissue and to heal. The patient is usually kept in hospital for a few days of strict bed rest, to prevent displacement of the plug and to encourage its incorporation.
Various plugs are available for this procedure.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.