Interventional procedure consultation document

Insertion of a collagen plug to close an abdominal wall enterocutaneous fistula

An enterocutaneous fistula is an abnormal opening between the bowel and the surface of the skin of the abdomen. It allows bowel contents to leak out and can be difficult to treat. This procedure uses a plug made of polyurethane and animal tissue (such as pig intestine) that is inserted through the fistula, with the aim of helping it to heal.

The National Institute for Health and Care Excellence (NICE) is examining insertion of a collagen plug to close an abdominal wall enterocutaneous fistula and will publish guidance on its safety and efficacy to the NHS. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about insertion of a collagen plug to close an abdominal wall enterocutaneous fistula.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

·      comments on the provisional recommendations

·      the identification of factual inaccuracies

·      additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

·      The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.

·      The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website.

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 28 August 2014

Target date for publication of guidance: November 2014

1                      Provisional recommendations

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 trusts.

·      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 is working with clinicians and manufacturers to develop a national register for the procedure.  When available, clinicians should submit details about all patients having this procedure and audit outcomes locally.

1.4                  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 prior treatments. NICE may review the procedure on publication of further evidence.

2                      Indications and current treatments

2.1                  An enterocutaneous fistula is an abnormal opening between the small or large bowel and the skin of the abdomen, which allows the contents of the bowel to leak. A fistula can arise from any part of the bowel (duodenum, jejunum, ileum, colon, or rectum). The most common predisposing conditions are inflammatory bowel disease and a history of bowel surgery or trauma.

2.2                  Management options include total parenteral nutrition, and measures to prevent intestinal contents from passing through the bowel, so decreasing fistula output and encouraging healing. Surgical options include primary repair with resection of the fistula track, with or without bowel diversion (creating a stoma).

3                      The procedure

3.1                  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 disk (disk used to retain the device in place). A radiopaque flange (or device footplate) attached to the internal end of the plug helps 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.

3.2                  Various plugs are available for use in this procedure.

4                      Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1                  In a case series of 6 patients, fistula closure was achieved for 100% (6/6) of fistulas at 2 weeks but the fistula recurred in 33% (2/6) of patients. In both patients, the fistulas recurred at 9 months. The first patient died from postoperative complications after additional surgical repairs (no further details provided). For the second patient, after a short period of drainage, the procedure was repeated without any further recurrence at 6 months. In a case series of 5 patients, fistula closure was achieved for 40% (2/5) of fistulas after a few days. When closure did not occur, 67% (2/3) were closed by further treatment (timing not reported) without any further recurrence at 18-month median follow-up (range 8 to 29 months). In a second case series of 5 patients, fistula closure was achieved for 80% (4/5) of fistulas at 80-day mean follow-up (range 30 to 120 days). In the remaining patient 2 separate procedures were done, 1 week apart, but closure was not achieved.

4.2                  The specialist advisers stated that the key efficacy outcomes are permanent fistula closure and avoidance of need for surgical repair.

5                      Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1                  Death was reported in 1 patient 1 month after the procedure, from coccidioidomycosis with multiple other chest and abdominal abscesses, in a case series of 5 patients. Death was reported in 1 patient 9 months after the procedure, as a result of postoperative complications after additional surgical repairs when the fistula reopened (no further details provided) in a case series of 6 patients.

5.2                  Device migration was reported in 2 patients (both from the case series of 6 patients). One patient presented with a recurrent pelvic abscess 7 weeks after the procedure. A colonic fistula and a small pericolic abscess, which contained the silicon footplate of the device, were identified. The colonic fistula was the recurrence of a separate defect previously closed with fibrin glue. The footplate was removed percutaneously and the abscess and fistula closed after 6 weeks of catheter drainage. In the other patient, a CT scan at 4 months showed that the device footplate had migrated out of the bowel lumen, causing a pre-sacral fluid collection. The footplate was removed percutaneously and a catheter left in for drainage. The fistula recurred 9 months after the enterocutaneous fistula plug placement and the patient died from the postoperative complications following the additional surgical repairs (death reported in the previous section).

5.3                  One patient was admitted to hospital 2 days after the procedure because of pyrexia (102.4^oF) in a case series of 2 patients: no cause was found and no further details were given. This patient had a further admission for small bowel obstruction that resolved within 2 days of nasogastric suction (timing not reported).

5.4                  The specialist advisers reported an anecdotal adverse event of severe pain during the procedure requiring conversion to general anaesthetic. They stated that theoretical adverse events could include allergic reaction, increase in diameter or output of the fistula, peritonitis and bowel contents leaking into the abdominal cavity, bowel injury, vascular injury and bleeding.

6                      Committee comments

6.1                  The Committee noted that the number of patients in the published studies was very small. However, it was advised that enterocutaneous fistulas can have a serious impact on quality of life and that the options available for patients are limited, especially if conservative management has failed or if surgery is unsuitable for them. Because of this and its judgement that serious safety problems are unlikely as a result of the procedure, the Committee considered it appropriate to recommend special arrangements with high quality data collection.

7                      Further information

7.1                  This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
July

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