Title: FIAT (Fistula-in-ano trial) comparing Surgisis® anal fistula plug versus surgeons preference (advancement flap fistulotomy cutting seton) for transsphincteric fistula-in-ano
Funder: Department of Health (England)

Abstract: Design: Prospective randomised multicentre trial of Surgisis® anal fistula plug versus surgeons 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 careSetting: Teaching and District General Hospitals in the United Kingdom. Participating surgeons will be members of the Association of Coloproctology of GB&ITarget Population: Inclusion and exclusion criteria are based on current recommendations regarding patient suitability and details of operative technique(6).Inclusion Criteria1.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 aetiologyExclusion 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 sphincter4.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 sepsis7.Cultural or religious objection to the use of pig tissueHealth 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


Research activity codes: 6.4 SURGERY
Health categories: ORAL AND GASTROINTESTINAL