Botulinum toxin injection versus lateral internal sphincterotomy for chronic anal fissure
A Prospective Comparative Study of Clinical Outcomes Between Botulinum Toxin Injection and Lateral Internal Sphincterotomy in the Management of Chronic Anal Fissure
This will try botulinum toxin injections versus a small surgical sphincterotomy to see which gives better healing and less pain for adults with chronic anal fissure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Islamabad Medical and Dental College Academic / other |
| Locations | 1 site (Islamabad, Federal) |
| Trial ID | NCT07568314 on ClinicalTrials.gov |
What this trial studies
Ninety adults with chronic anal fissure who have not improved with conservative care will be enrolled and split into two groups, one receiving botulinum toxin type A injections and the other undergoing lateral internal sphincterotomy. Patients will be followed regularly to record healing, pain relief, recurrence, and any complications such as incontinence. Botulinum toxin is a minimally invasive, temporary muscle relaxant, while sphincterotomy is a minor surgery that permanently reduces sphincter pressure and has high reported healing rates. Outcomes will compare short-term recovery, long-term fissure closure, recurrence rates, and adverse events between the two approaches.
Who should consider this trial
Good fit: Adults aged 18–65 with chronic anal fissure lasting more than 6 weeks who have failed conservative treatment, have no prior anal surgery, no inflammatory bowel disease, are not pregnant, have no relevant neurological disorders, and can give informed consent are ideal candidates.
Not a fit: Patients with acute fissures, prior anal surgery, inflammatory bowel disease, pregnancy, neurological continence disorders, or known allergy to botulinum toxin are unlikely to qualify or benefit from enrollment.
Why it matters
Potential benefit: If successful, the less invasive botulinum toxin approach could offer comparable healing with faster recovery and lower immediate surgical risk for some patients.
How similar studies have performed: Previous research shows lateral internal sphincterotomy has high healing rates while botulinum injections can heal fissures but generally have higher recurrence, so comparing the two is consistent with existing clinical evidence rather than wholly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:Age 18-65 years Diagnosed chronic anal fissure (\>6 weeks duration) Failure of conservative management Both male and female patients Willingness to provide informed consent - Exclusion Criteria:Acute anal fissure Previous anal surgery Inflammatory bowel disease Pregnancy Neurological disorders affecting continence Known hypersensitivity to botulinum toxin \-
Where this trial is running
Islamabad, Federal
- Islamabad Medical and Dental College — Islamabad, Federal, Pakistan (Recruiting)
Study contacts
- Study coordinator: Prof.Dr Rizwan Aziz
- Email: aziz.rizwan@imdcollege.edu.pk
- Phone: +923008444229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.