Surgeons are running a head-to-head trial of a bioprosthetic plug made from pig tissue against three standard surgical techniques for treating high anal fistulas—a common but debilitating condition that causes pain, discharge, and incontinence. The problem is that no one knows which operation works best. Each existing technique—fistulotomy, advancement flap, or cutting seton—carries a trade-off between healing the fistula and preserving continence. The plug, made from porcine intestinal submucosa, is designed to seal the tract without cutting muscle, but its effectiveness compared to surgeon’s choice has never been tested in a randomised trial. If the plug proves superior or equivalent in preserving quality of life—measured by validated incontinence and generic health scores—it could become the preferred first-line treatment, reducing the risk of faecal incontinence that haunts patients after conventional surgery. This would directly improve daily life for thousands of people with a condition that is often hidden and under-treated. The trial is not fundamental science; it is a pragmatic comparison of existing technologies to settle a long-standing clinical uncertainty.
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Design: Prospective, randomised, multicentre trial of Surgisis® anal fistula plug versus surgeon's preference (fistulotomy, advancement flap, or cutting seton) in the treatment of high transsphincteric anal fistulae.It is not practicably possible to perform a blinded comparison given the nature of the procedures and the specifics of the postoperative care Setting: Teaching and District General Hospitals in the United Kingdom. Participating surgeons will be members of the Association of Coloproctology of GB&I Target Population: Inclusion and exclusion criteria are based on current recommendations regarding patient suitability and details of operative technique(6). Inclusion Criteria 1.Clinical diagnosis of high transsphincteric cryptoglandular fistula-in-ano. A high transsphincteric fistula is defined as a fistula involving 1/3 or more of the external anal sphincter muscle as assessed by clinical examination or radiological imaging. 2.Patients must have undergone a prior examination under anaesthesia (EUA) to characterise the nature of the fistula. 3.The fistula tract should be greater or equal to 2cm in length. 4.Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation. 5.Patients must be 18 years or older and able to provide informed consent. 6.Fistulae must be cryptoglandular aetiology Exclusion criteria: 1.Unable/unwilling to provide informed consent. 2.Contraindication to general anaesthesia. 3 Low transsphincteric fistulae involving less than 1/3 of the external anal sphincter 4.Non-cryptoglandular fistulae e.g Crohns, obstetric, irradiation, malignant etc. 5.Other perineal fistulae e.g rectovaginal fistulae, pouch-vaginal fistulae etc. 6.Evidence of active perianal sepsis 7.Cultural or religious objection to the use of pig tissue Health Technologies Being Assessed: Surgisis® anal fistula plug (Cook Medical, Indiana, USA). Surgisis® has CE-approval and is the only bioprosthetic plug specifically designed for the treatment of anal fistulae. Measurement of cost and outcome: Primary outcomes: 1. Quality of life (QoL): assessed by validated symptom-specific QoL instrument, Faecal Incontinence Quality of Life Questionnaire(7), and generic EQ-5D utility and visual analogue scores(8), at baseline, 6 weeks, 6 and 12 months. Quality of life has been chosen as the primary outcome measure, rather than fistula healing rate, to reflect the primary aim of fistula surgery; to produce relief of symptoms whilst maintaining anal sphincter function and preserving symptom-specific (incontinence) QoL. The reported rates of fistula healing varies considerably in the literature, with no obvious superiority between fistula plug, advancement flap, fistulotomy, or cutting seton. The main difference between these techniques is likely to be the functional outcome in terms of preservation of continence and QoL. Further, "fistula healing" is difficult
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