| Objective: |
The FIAT trial is a pragmatic, multi-centre, randomised controlled trial designed to provide reliable evidence on the value of the Biodesign? Surgisis? anal fistula plug in the treatment of high fistula-in-ano. |
| Aim: |
"FIAT is a pragmatic, Phase III multi-centre randomised controlled trial with the following objectives: Primary objective: To compare the Biodesign® Surgisis® anal fistula plug with standard treatments for high trans- sphincteric anal fistulae in terms of:
• symptom-specific quality of life.
Secondary objectives:
To compare the Biodesign® Surgisis® anal fistula plug with standard techniques for high transsphincteric anal fistulae in terms of:
• fistula healing rates
• complication and re-intervention rates
• faecal incontinence rates
• cost-effectiveness
• health economic benefits. "
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| Methods: |
Patients with a confirmed high transsphincteric fistula at risk of incontinence with fistulotomy (involving approximately 1/3 or more of the external sphincter complex), will be randomised between insertion of the Biodesign® Surgisis® fistula plug and the surgeons preference of advancement flap, cutting seton, fistulotomy and the LIFT procedure.
Eligibility Criteria Inclusion criteria
1. Clinical diagnosis of high transsphincteric cryptoglandular fistula-in-ano.
2. Patients must have undergone a prior EUA to characterise the nature of the fistula. 3. The fistula tract should be ? 2cm in length.
4. Only a single internal fistula opening should be present at EUA, such that the fistula is suitable for treatment by insertion of a single fistula plug.
5. Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation.
6. Patients must be 18 years or older and able to provide informed consent.
7. Fistulae must be cryptoglandular aetiology.
Exclusion criteria
1. Unable/unwilling to provide informed consent.
2. Contraindication to general anaesthesia.
3. Low transsphincteric fistulae.
4. Non-cryptoglandular fistulae e.g. Crohns, obstetric, irradiation, malignant etc.
5. Other perineal fistulae e.g. rectovaginal fistulae, pouch-vaginal fistulae etc.
6. Complex disease in which more than one internal fistula opening is present and requiring concurrent insertion of more than one fistula plug.
7. Clinical evidence of active perianal sepsis. In the event that there is disagreement between clinical and radiological assessment of active sepsis/collection, the clinical opinion will prevail.
8. Cultural or religious objection to the use of pig tissue.
9. Absolute contraindication to MRI scan e.g. cardiac pacemaker.
10. Patients with recurrent anal fistulae previously treated with a fistula plug.
FIAT aims to randomsie 300 patients in a 1:1 ratio between the fiatula plug and 'Surgeon's Preference'. |
| Reason for International Trial: |
This study will close to recruitment at the end of Feb 2016, the trial will not recruit internationally. |
