Idiopathic anal fistulas deemed unsuitable for fistulotomy Digestive System Fissure and fistula of anal and rectal regions
Conditions
Interventions
This is a randomised single-blind controlled study performed at two london (UK) hospitals, the Royal London Hospital and the Homerton University Hospital.
Intervention 1: Solid Permacol® implant
In
syringe 2: thrombin and collagen fibres suspended in calcium chloride solution), which were subsequently placed in a Duploject™ (Baxter AG) two-syringe clip, where they shared a common plunger. A plas
Sponsors
Queen Mary, University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients, over 18-years, with an idiopathic anal fistula, under the care of a single surgeon, in whom fistulotomy was deemed unsuitable (on the basis of the fistula type and level, threat to continence or patient choice).
Exclusion criteria
Exclusion criteria: Patients with either clinical or radiological (magnetic resonance imaging) evidence of secondary tracts or acute sepsis were excluded from the trial until these had been eradicated, leaving a single primary tract.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety of procedure, defined as no acute perineal sepsis or anal incontinence at 3 months post intervention. Assessed by symptom and continence questionnaires, clinical examination, anal manometry, and endoanal ultrasound. All peformed at 3 months post-intervention. 2. Success of procedure assessed by symptom questionnaire and clinical examination at 3, 6, 9, 12 and 18-months post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| The following were assessed by a patient questionnaire at 3-months post-intervention: 1. Time taken for perineal wound to heal 2. Time taken to return to work | — |
Countries
United Kingdom
Outcome results
None listed