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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
INTERVENTION: 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. We wish to look at two different kinds of surgery which do not have any risk of disturbing continence, and decide which is superior in managing anal fissure. The first is surgical removal of the fissure together with an injection of botox. The second is surgical removal of the fissure with a flap of skin to cover the wound. Both techniques avoid cutting of the 'sphincter' and so do not disturb continence. Added 28 August 2008: trial stopped due to poor recruitment. CONDITION: Surgery: Fissurectomy ; Surgery ; Fissurectomy PRIMARY OUTCOME: Healing rates of anal fissure at 4, 12 and 24 weeks post surgery. SECONDARY OUTCOME: 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 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
Epistemonikos ID: 18ede15716413d92f50af53f5e1cbeb881e34b70
First added on: Aug 21, 2024