The FIAT Trial is a phase III, multi-centre, randomised, controlled test intended to establish an evidence base for whether the Biodesign Fistula Plug can offer relief to patients with anal fistula while maintaining sphincter function and improving their quality of life.
Until now, the more widely used treatments for the condition have involved more intensive surgery, which can compromise the sphincter muscles, leaving patients, many of whom are fairly young, at risk of permanent faecal incontinence.
The fact there are numerous ways to treat the problem speaks volumes because if there was just one way, it would be a good way. But nearly all have downsides
David Jayne, a consultant general surgeon at Leeds General Infirmary, is the chief investigator for the trial and said that, if it was proven the new plug was effective, it would be a 'massive step forward' for patients and medics. He explained: "Anal fistula is a fairly common condition that causes recurrent abscesses on the bottom. It is difficult to treat because you are operating on an area where the sphincter muscles are located and, if you cut these, you can make the patient incontinent. If that happens it is permanent. The fact there are numerous ways to treat the problem speaks volumes because if there was just one way, it would be a good way. But nearly all have downsides."
This uncertainty led to the creation of the Biodesign Fistula Plug, which is a minimally-invasive natural solution that uses a collagen scaffold to promote growth of surrounding cells. The result is fully remodelled tissue and complete fistula closure without risk of muscle damage. There is also no wound in the bottom, so there is less need for district nurse follow-up care.
Jayne said: "It is a very straightforward technique and the plug is very simple to use, but we have got to prove that it works. Currently it is not supported by all hospital trusts because there is not the evidence base and it costs more initially compared to traditional solutions."
He said early testing had found the plug to be around 60% effective, similar to other techniques, but he added: "It involves only a very short stay in hospital and post-operative pain is minimal, so recovery is quick.
"What we need to know now is healing rate efficacy because, if we find it heals more than 50% of patients, but prevents continence problems, then it will be a winner in comparison to other solutions. It is a very exciting breakthrough."
Unlike many clinical trials, which involve just one or two centres and a handful of patients, the FIAT trial has attracted more than 500 people and dozens of surgeons from 50 trusts and organisations up and down the country. Funded by the Health Technology Assessment Programme and developed by the Research and Audit Committee of the Association of Coloproctology of Great Britain and Ireland and the University of Birmingham clinical trials unit, the investigation will enable formal evaluation to take place, with detailed results expected in 2015.
Prior to the start of the trial, a series of workshops has been held to train more than 70 surgeons and dozens of radiologists in using the plug. Jayne said: "It is vital that we train those clinicians who will be carrying out the procedure, so they are all using the same approach and their results can be fairly compared.
It's a win-win situation. Surgeons are getting access to new techniques their trusts might not usually fund, and patients are potentially getting a treatment that carries less risk
"Our primary objective is to identify whether the plug will lead to an improved quality of life for patients by reducing the number of symptoms after surgery. However, it is also important that it also demonstrates health economic benefits and is cost effective against standard surgical techniques for fistula treatment."
Cook Medical is providing the plugs free of charge to those involved in the trial, but the analysis itself is being done independently. Jayne said: "It's a win-win situation. Surgeons are getting access to new techniques their trusts might not usually fund, and patients are potentially getting a treatment that carries less risk.
This is something surgeons have been waiting for and we hope it will prove to be a breakthrough in care
"This is something surgeons have been waiting for and we hope it will prove to be a breakthrough in care. It is also evidence that research and development is continuing in the health sector as there is concern that innovation will be compromised by the current cuts in funding. It is a good sign that we will continue to see developments in the MedTech sector."
Andy Cron, global leader of Cook Medical's surgery strategic business unit, added: "The plug is an effective way to repair anal skin tissue breaches in patients and we hope the trial will show how beneficial it is in maximising patient care while still remaining a cost-effective treatment option. Essentially we are looking to produce an enhanced level of care for patients through a standardised treatment and procedure using Biodesign."