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

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 effect 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.