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31 PagesPosted: 17 Apr 2019
See all articles by David Jayne
David Jayne
Leeds Teaching Hospitals NHS Trust - The John Goligher Colorectal Surgery Unit
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
Independent
More...
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: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 or http://dx.doi.org/10.2139/ssrn.3372428
David Jayne (Contact Author)
Leeds Teaching Hospitals NHS Trust - The John Goligher Colorectal Surgery Unit ( email )
Leeds, LS9 7TF
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
