A multicentre randomised controlled trial comparing safety, efficacy, and costeffectiveness of the Surgisis® anal fistula plug versus surgeon’s preference for transsphincteric fistula-in-ano: the FIAT trial

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@article{ac86c4ec54bd4edda10f0ac49c144dcb,
title = "A multicentre randomised controlled trial comparing safety, efficacy, and costeffectiveness of the Surgisis{\textregistered} anal fistula plug versus surgeon{\textquoteright}s preference for transsphincteric fistula-in-ano: the FIAT trial",
abstract = "Objective: To undertake a randomised comparison of the Biodesign Surgisis anal fistula plug against surgeon{\textquoteright}s preference in treating cryptoglandular transsphincteric fistula-in-ano. Summary Background Data: The efficacy of the Biodesign Surgisis anal fistula plug in healing anal fistulae is uncertain. Methods: Participants were randomised to the fistula plug with surgeon{\textquoteright}s preference (advancement flap, cutting seton, fistulotomy, LIFT procedure). The primary outcome was faecal incontinence quality of life (FIQoL) at 12-months. Secondary outcomes were fistula healing, incontinence rates, and complication and re-intervention rates. Results: Between May 2011 and March 2016, 304 participants were randomised to fistula plug or surgeon{\textquoteright}s preference. No differences were seen in FIQoL between the two groups at 12-months. Clinical fistula healing was reported in 66/122 (54%) of the fistula plug and 66/119 (55%) of the surgeon{\textquoteright}s preference groups at 12-months. Faecal incontinence rates improved marginally in both groups. Complications and re-interventions were frequent, with significantly more complications in the fistula plug group at 6-weeks (49/142, 35% vs. 25/137, 18%; p=0.002). The mean total costs were £2,738 (s.d. £1,151) for the fistula plug and £2,308 (s.d. £1,228) for the surgeon{\textquoteright}s preference group (mean difference +£430, p=0.0174). The average total QALYs gained was marginally higher in the fistula plug group. The fistula plug was 35% - 45% likely to be cost-effective across a willingness to pay threshold of £20,000-£30,000 / QALY. Conclusions: The Biodesign Surgisis{\textregistered} anal fistula plug is associated with similar FIQoL and healing rates to surgeon{\textquoteright}s preference at 12-months. Higher costs and highly uncertain gains in QALYs mean that the fistula plug may not be considered as a cost-effective treatment in the UK NHS. ",
author = "David Jayne and John Scholefield and Damian Tolan and Richard Gray and Asha Senapati and Claire Hulme and Andrew Sutton and Kelly Handley and Catherine Hewitt and Manjinder Kaur and Laura Magill",
year = "2020",
month = jun,
day = "9",
doi = "10.1097/SLA.0000000000003981",
language = "English",
journal = "Annals of surgery",
issn = "0003-4932",
publisher = "Lippincott Williams and Wilkins",

}

RIS

TY - JOUR

T1 - A multicentre randomised controlled trial comparing safety, efficacy, and costeffectiveness of the Surgisis® anal fistula plug versus surgeon’s preference for transsphincteric fistula-in-ano

T2 - the FIAT trial

AU - Jayne, David

AU - Scholefield, John

AU - Tolan, Damian

AU - Gray, Richard

AU - Senapati, Asha

AU - Hulme, Claire

AU - Sutton, Andrew

AU - Handley, Kelly

AU - Hewitt, Catherine

AU - Kaur, Manjinder

AU - Magill, Laura

PY - 2020/6/9

Y1 - 2020/6/9

N2 - Objective: To undertake a randomised comparison of the Biodesign Surgisis anal fistula plug against surgeon’s preference in treating cryptoglandular transsphincteric fistula-in-ano. Summary Background Data: The efficacy of the Biodesign Surgisis anal fistula plug in healing anal fistulae is uncertain. Methods: Participants were randomised to the fistula plug with surgeon’s preference (advancement flap, cutting seton, fistulotomy, LIFT procedure). The primary outcome was faecal incontinence quality of life (FIQoL) at 12-months. Secondary outcomes were fistula healing, incontinence rates, and complication and re-intervention rates. Results: Between May 2011 and March 2016, 304 participants were randomised to fistula plug or surgeon’s preference. No differences were seen in FIQoL between the two groups at 12-months. Clinical fistula healing was reported in 66/122 (54%) of the fistula plug and 66/119 (55%) of the surgeon’s preference groups at 12-months. Faecal incontinence rates improved marginally in both groups. Complications and re-interventions were frequent, with significantly more complications in the fistula plug group at 6-weeks (49/142, 35% vs. 25/137, 18%; p=0.002). The mean total costs were £2,738 (s.d. £1,151) for the fistula plug and £2,308 (s.d. £1,228) for the surgeon’s preference group (mean difference +£430, p=0.0174). The average total QALYs gained was marginally higher in the fistula plug group. The fistula plug was 35% - 45% likely to be cost-effective across a willingness to pay threshold of £20,000-£30,000 / QALY. Conclusions: The Biodesign Surgisis® anal fistula plug is associated with similar FIQoL and healing rates to surgeon’s preference at 12-months. Higher costs and highly uncertain gains in QALYs mean that the fistula plug may not be considered as a cost-effective treatment in the UK NHS.

AB - Objective: To undertake a randomised comparison of the Biodesign Surgisis anal fistula plug against surgeon’s preference in treating cryptoglandular transsphincteric fistula-in-ano. Summary Background Data: The efficacy of the Biodesign Surgisis anal fistula plug in healing anal fistulae is uncertain. Methods: Participants were randomised to the fistula plug with surgeon’s preference (advancement flap, cutting seton, fistulotomy, LIFT procedure). The primary outcome was faecal incontinence quality of life (FIQoL) at 12-months. Secondary outcomes were fistula healing, incontinence rates, and complication and re-intervention rates. Results: Between May 2011 and March 2016, 304 participants were randomised to fistula plug or surgeon’s preference. No differences were seen in FIQoL between the two groups at 12-months. Clinical fistula healing was reported in 66/122 (54%) of the fistula plug and 66/119 (55%) of the surgeon’s preference groups at 12-months. Faecal incontinence rates improved marginally in both groups. Complications and re-interventions were frequent, with significantly more complications in the fistula plug group at 6-weeks (49/142, 35% vs. 25/137, 18%; p=0.002). The mean total costs were £2,738 (s.d. £1,151) for the fistula plug and £2,308 (s.d. £1,228) for the surgeon’s preference group (mean difference +£430, p=0.0174). The average total QALYs gained was marginally higher in the fistula plug group. The fistula plug was 35% - 45% likely to be cost-effective across a willingness to pay threshold of £20,000-£30,000 / QALY. Conclusions: The Biodesign Surgisis® anal fistula plug is associated with similar FIQoL and healing rates to surgeon’s preference at 12-months. Higher costs and highly uncertain gains in QALYs mean that the fistula plug may not be considered as a cost-effective treatment in the UK NHS.

U2 - 10.1097/SLA.0000000000003981

DO - 10.1097/SLA.0000000000003981

M3 - Article

JO - Annals of surgery

JF - Annals of surgery

SN - 0003-4932

ER -