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Randomised controlled trial of fissurectomy and botulinum toxin injection versus island flap in the management of chronic anal fissure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55110272
Enrollment
70
Registered
2006-09-29
Start date
2005-08-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery: Fissurectomy Surgery Fissurectomy

Interventions

Anal fissure is a painful type of ulcer around the anal canal. It often does not respond to topical therapy and surgery has to be considered. Current treatment has a risk of incontinence after surgery

Sponsors

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Concurrent peri-anal disease 2. Previous fissure surgery

Design outcomes

Primary

MeasureTime frame
Healing rates of anal fissure at 4, 12 and 24 weeks post surgery.

Secondary

MeasureTime frame
1. Pain on defecation as assessed by Visual analogue score for 10 days post surgery 2. Patient's general health as assessed by SF-12 questionnaire at 24 weeks 3. Continence at 4, 12 and 24 weeks post surgery as assessed by the Cleveland incontinence score

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026