Management of idiopathic anal fistula using collage
Completed
- Conditions
- Idiopathic anal fistulas deemed unsuitable for fistulotomyDigestive SystemFissure and fistula of anal and rectal regions
- Registration Number
- ISRCTN67277406
- Lead Sponsor
- Queen Mary, University of London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>2. Success of procedure assessed by symptom questionnaire and clinical examination at 3, 6, 9, 12 and 18-months post-intervention
- Secondary Outcome Measures
Name Time Method The following were assessed by a patient questionnaire at 3-months post-intervention:<br>1. Time taken for perineal wound to heal<br>2. Time taken to return to work