None listed
Conditions
Brief summary
This study aims to determine if a lower dose of botulinum toxin (Botox) (40 IU) is as effective as a higher dose (100 IU) for the treatment of chronic anal fissures. Eligible adult participants will be randomised to receive either a lower dose or a higher dose of Botox, injected into the anal sphincters under anaesthesia, and invited to participate in a 2-part simple questionnaire, the first part at the time of recruitment, and the second part at the final follow-up appointment at 12 weeks post-procedure.
Interventions
To determine the efficacy of a higher dose of botulinum toxin (100 IU) against a lower dose.
- Administered by the attending colorectal surgeon at the time of the examination under anaesthesia and fissurectomy.
- Mode of administration: intersphincteric injection
- Duration of intervention: once off
- Strategies used to assess adherence: no
Sponsors
Eastern Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients over the age of 18 who are able to provide consent, and are diagnosed with a chronic anal fissure, with duration of symptoms 6 weeks or longer.
Exclusion criteria
• Previous surgical management for fissure • Previous anal surgery • Fissure fistula • Crohn’s disease (based on (i) history and (ii) the patient is taking medication for management of their disease) • Rectal or anal malignancy • History of faecal incontinence • HIV/AIDS • Syphilis • Presence of perianal sepsis or fistula or fissure fistula • Currently pregnant or breastfeeding • Unable to complete trial questionnaires or attend follow up
Outcome results
None listed