Botulinum toxin for the treatment of anal fistulae - a double blinded randomized trial

Phase 2

Recruiting

Conditions: Anal fistula
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Registration Number: ACTRN12620000094976

Lead Sponsor: Dept Surgery, Deakin University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Complex anal fistula with Seton drain in situ

Exclusion Criteria

•Patients with known Crohn’s disease of anorectal malignancy.
•Patients with rectovaginal or anovaginal fistulae.
•Patients with known generalised musculoskeletal disease.
•Patients with known sensitivity to Botox.
•Pregnant or breast- feeding women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healing of fistula<br>The fistula will be judged to have healed if the following criteria are met:<br>•The external opening has healed.<br>•The internal opening cannot be palpated on digital rectal examination.<br>•The patient does not complain of any ongoing drainage from the fistula site.<br>This will be assessed by a specialist surgeon investigator who will be blindd to the treatment arm.[ 3 weeks post- procedure]

Secondary Outcome Measures

Name	Time	Method
Faecal incontinence<br>The presence and severity of faecal incontinence will be documented using the St. Mark’s Incontinence Score. This is a self- reported assessment of the patient’s experience of their continence. It includes both objective statements of the frequency of incontinence episodes (to solid or liquid stool or flatus) as well as a more general perception of how frequently incontinence affects their lifestyle. This is a widely used and well validated questionnaire, the results of which have been shown to correlate well with other measures of quality of life.[ 24 weeks post procedure]