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A Multicentre Randomised Controlled Trial Comparing Safety, Efficacy, and Cost-Effectiveness of the Surgisis® Anal Fistula Plug versus Surgeon's Preference for Transsphincteric Fistula-in-Ano: The FIAT Trial

31 Pages Posted: 17 Apr 2019

See all articles by David Jayne

David Jayne

University of Leeds

John Scholefield

University of Nottingham - Faculty of Medicine and Health Sciences

Damian Tolan

Government of the United Kingdom - Leeds Teaching Hospitals

Richard Gray

University of Oxford

Asha Senapati

Government of the United Kingdom - Portsmouth Hospitals NHS Trust

Claire T. Hulme

Leeds Institute of Health Sciences - Academic Unit of Health Economics

Andrew Sutton

Institute of Health Economics

Kelly Handley

University of Birmingham

Catherine Hewitt

University of Birmingham

Manjinder Kaur

University of Birmingham

Laura Magill

University of Birmingham

FIAT Trial Collaborative Group

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Abstract

Background: The Biodesign Surgisis anal fistula plug preserves continence, but its efficacy in healing anal fistulae is uncertain.

Methods: A randomised trial involving 40 UK hospitals comparing the fistula plug with surgeon's preference (advancement flap, cutting seton, fistulotomy, LIFT procedure) for cryptoglandular transsphincteric anal fistulae. Randomisation was a one-to-one, minimised by age, ASA grade, planned surgery, and presence of secondary tracts. 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. A trial-based cost-utility analysis was undertaken.

Findings: Between May 2011 and March 2016, 304 participants were equally 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 showed a marginal improvement 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. Using multiple imputation and probabilistic sensitivity analysis the fistula plug was 35%-45% likely to be costeffective across a willingness to pay threshold of £20,000-£30,000/QALY.

Interpretation: 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.

Trial Registration Number: (ISRCTN 78352529).

Funding Statement: The FIAT trial was funded by the NIHR Health Technology Assessment Programme - 07/89/01.

Declaration of Interests: The authors declare no competing interests.

Ethics Approval Statement: Ethical committee approval was obtained (10/H0405/29). The trial was overseen by an independent Trial Steering Committee and Data Monitoring and Ethics Committee.

Suggested Citation

Jayne, David and Scholefield, John and Tolan, Damian and Gray, Richard and Senapati, Asha and Hulme, Claire T. and Sutton, Andrew and Handley, Kelly and Hewitt, Catherine and Kaur, Manjinder and Magill, Laura and Group, FIAT Trial Collaborative, A Multicentre Randomised Controlled Trial Comparing Safety, Efficacy, and Cost-Effectiveness of the Surgisis® Anal Fistula Plug versus Surgeon's Preference for Transsphincteric Fistula-in-Ano: The FIAT Trial (April 15, 2019). Available at SSRN: https://ssrn.com/abstract=3372428

David Jayne (Contact Author)

University of Leeds ( email )

Leeds, LS2 9JT
United Kingdom

John Scholefield

University of Nottingham - Faculty of Medicine and Health Sciences ( email )

Nottingham, NG7 2RD
United Kingdom

Damian Tolan

Government of the United Kingdom - Leeds Teaching Hospitals

Leeds, West Yorkshire LS1 3EX
United Kingdom

Richard Gray

University of Oxford

Mansfield Road
Oxford, Oxfordshire OX1 4AU
United Kingdom

Asha Senapati

Government of the United Kingdom - Portsmouth Hospitals NHS Trust

Portsmouth
United Kingdom

Claire T. Hulme

Leeds Institute of Health Sciences - Academic Unit of Health Economics

Leeds Institute of Health Sciences
101 Clarendon Road
Leeds, LS2 9LJ
United Kingdom

Andrew Sutton

Institute of Health Economics

Edmonton
Canada

Kelly Handley

University of Birmingham

Edgbaston, Birmingham B15 2TT
United Kingdom

Catherine Hewitt

University of Birmingham

Edgbaston, Birmingham B15 2TT
United Kingdom

Manjinder Kaur

University of Birmingham

Edgbaston, Birmingham B15 2TT
United Kingdom

Laura Magill

University of Birmingham

Edgbaston, Birmingham B15 2TT
United Kingdom

No contact information is available for FIAT Trial Collaborative Group

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