Plain English Summary
Background and study aims
An anal fistula is a small channel that develops between the end of the bowel and the skin near the anus. Common symptoms include skin irritation, pain, and a discharge of pus or blood when having a bowel movement. Anal fistulas are usually classed as either low or high depending on its position and how close it is to the sphincter muscles (the rings of muscles that open and close the anus). Most are low fistulae and are amenable to treatment, but high fistulae pose a difficult problem. Traditional surgical methods of cutting open the whole length of the fistula (fistulotomy) cut that portion of the sphincter involved in the fistula and put the patient at risk of permanent faecal incontinence. A variety of new procedures have been advocated to prevent this but none have achieved high healing rates combined with a low incidence of incontinence. The Surgisis® anal fistula plug has the advantages that it’s simple to insert with minimal patient discomfort and the anal sphincter is preserved, with the potential for retaining full continence. However, the plug is relatively expensive and to justify its use we need to have more data regarding its effectiveness. This study will compare the continence and quality of life of patients treated with the Surgisis® anal fistula plug versus the standard treatment (surgery).
Who can participate?
Patients aged over 18 with high anal fistula (fistula tracts over 2 cm long, only one internal opening).
What does the study involve?
Most of the treatment patients receive is the same as they would receive if they were not in the study. There are no extra clinic visits, blood tests, or operations required beyond normal care. There is however some additional information that we would need to collect about the treatment and its effects. Patients are required to undergo an MRI scan and an examination under anaesthetic to assess the fistula; both of these are routine for patients with high anal fistula. If the fistula is suitable for treatment with a fistula plug, patients are asked to participate in the study. Participants are randomly allocated to be treated with either the standard treatment (surgery) or insertion of a fistula plug. Participants allocated to standard surgical treatment decide with their doctor which of the four types of surgery is best for them. After treatment we collect information about any complications, whether the fistula has healed, any change in continence, and we ask participants to complete a short questionnaire on their quality of life. Most of this information is collected at routine out-patient appointments, although some information may be collected by means of questionnaires sent by post. All information collected is strictly confidential in the same way as other medical records. Participants also undergo a second MRI scan one year after treatment. This second MRI scan is not part of routine care and is performed to determine whether or not the fistula has healed. After that, the participants’ progress is followed-up once a year.
What are the possible benefits and risks of participating?
There are no direct benefits from participating in the study. It is not clear whether fistula plugs are better or worse than conventional treatment; it is one of the aims of the study to find this out. A possible benefit of the fistula plug is that it will not affect continence. We cannot promise the study will help but participation in the study will provide valuable information on the treatment of anal fistula, and this will be used for the benefit of future patients.
Where is the study run from?
The study is run within 47 hospitals within the UK. The lead site is St James’s University Hospital, Leeds. The study is coordinated through the Birmingham Clinical Trials Unit, University of Birmingham.
When is the study starting and how long is it expected to run for?
November 2010 to May 2017.
Who is funding the study?
National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme.
Who is the main contact?
Prof. David Jayne
D.G.Jayne@leeds.ac.uk
d.jayne@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Mr David Jayne
ORCID ID
Contact details
Academic Surgical Unit
University of Leeds
Level 7 Clinical Sciences Building
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
-
david.jayne@leedsth.nhs.uk
Type
Scientific
Additional contact
Dr - -
ORCID ID
Contact details
The FIAT Trial
Birmingham Clinical Trials Unit (BCTU)
Institute of Applied Health Research
College of Medical and Dental Sciences
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 415 9105
FIAT@contacts.bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 07/89/01; 3.1 (Dated 07/04/2014)
Study information
Scientific title
Surgisis® anal fistula plug versus surgeon's preference (advancement flap, fistulotomy, cutting seton) for transsphincteric fistula-in-ano: a multicentre phase III randomised controlled trial
Acronym
FIAT
Study hypothesis
The FIAT trial is a pragmatic, multi-centre, randomised controlled trial designed to provide reliable evidence on the value of the Surgisis® anal fistula plug in the treatment of high fistula-in-ano.
The study will evaluate the clinical and cost-effectiveness of the Surgisis® anal fistula plug against the standard surgical techniques routinely used to treat cryptogenic transsphincteric anal fistulae. The standard surgical techniques have been grouped as a single comparator and termed "Surgeon's Preference", and include the use of advancement flap, fistulotomy, or a cutting seton. Efficacy will be measured in terms of preservation of symptom-specific quality of life (QoL), fistula healing rates, faecal incontinence scores, complication and re-intervention rates, and heath economics and cost-effectiveness.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/078901
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0009/51939/PRO-07-89-01.pdf
Ethics approval
Trent Research Ethics Committee, 07/06/2010, ref: 10/H0405/29
Study design
Multicentre phase III randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
High transsphincteric fistula-in-ano
Intervention
Fistula plug versus surgeon's preference which can be either:
1. Advancement flap
2. Fistulotomy
3. Cutting seton
4. LIFT Procedure (added 06/01/2016)
Total duration of treatment: The patient will be randomised and then have surgery within that week. They will then be followed up at 6 weeks, 6 months and 12 months.
Total duration of follow-up: Currently funded to follow all patients up to 12 months but this will be extended for annual follow-up until at least 3 years.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Symptom-specific quality of life as assessed by the validated Faecal Incontinence Quality of Life Scale and supplemented with collection of generic EQ-5D data and visual analogue scores. Assessments will be at baseline, 6 weeks, 6 and 12 months.
Secondary outcome measures
1. Fistula healing rate at 12 months
2. Faecal incontinence at baseline, 6 and 12 months
3. Complication rates
4. Re-intervention rates
5. Health resource utilisation
6. Cost-effectiveness
Overall trial start date
05/01/2010
Overall trial end date
31/05/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Clinical diagnosis of high transsphincteric cryptoglandular fistula-in-ano. A high transsphincteric fistula is defined as a fistula involving greater than or equal to 1/3 of the external anal sphincter muscle as assessed by clinical examination or radiological imaging.
2. Patients must have undergone a prior examination under anaesthesia (EUA) to characterise the nature of the fistula
3. The fistula tract should be greater than 2 cm in length
4. Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation
5. Patients must be 18 years or older, either sex, and able to provide informed consent
6. Fistulae must be cryptoglandular aetiology
Added 06/01/2016:
7. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
306
Total final enrolment
304
Participant exclusion criteria
1. Unable/unwilling to provide informed consent
2. Contraindication to general anaesthesia
3. Low transsphincteric fistulae involving less than 1/3 of the external anal sphincter
4. Non-cryptoglandular fistulae, e.g. Crohns, obstetric, irradiation, malignant, etc.
5. Other perineal fistulae, e.g. rectovaginal fistulae, pouch-vaginal fistulae, etc.
6. Evidence of active perianal sepsis
7. Cultural or religious objection to the use of pig tissue
Added 06/01/2016:
8. Complex disease in which more than one internal fistula opening is present and requiring concurrent insertion of more than one fistula plug
9. Absolute contraindication to MRI scan e.g. cardiac pacemaker
10. Patients with recurrent anal fistulae previously treated with a fistula plug
Recruitment start date
01/05/2011
Recruitment end date
28/02/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Surgical Unit
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
-
Leeds
LS2 9JT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
01/12/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31113531 (added 23/05/2019).