Randomised controlled trial of fissurectomy and botulinum toxin injection versus island flap in the management of chronic anal fissure
Completed
- Conditions
- Surgery: FissurectomySurgeryFissurectomy
- Registration Number
- ISRCTN55110272
- Lead Sponsor
- Record Provided by the NHSTCT Register - 2006 Update - Department of Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
1. Chronic anal fissure resistant to 6 weeks GTN therapy
2. Features of fissure chronicity (skin tag, induration)
3. Suitable for day case surgery
Exclusion Criteria
1. Concurrent peri-anal disease
2. Previous fissure surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Healing rates of anal fissure at 4, 12 and 24 weeks post surgery.
- Secondary Outcome Measures
Name Time Method 1. Pain on defecation as assessed by Visual analogue score for 10 days post surgery <br>2. Patient's general health as assessed by SF-12 questionnaire at 24 weeks<br>3. Continence at 4, 12 and 24 weeks post surgery as assessed by the Cleveland incontinence score