High transsphincteric fistula-in-ano Digestive System Fissure and fistula of anal and rectal regions
Conditions
Interventions
Fistula plug versus surgeon's preference which can be either:
1. Advancement flap
2. Fistulotomy
3. Cutting seton
4. LIFT Procedure (add
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed