Botox injections alone vs with fissurectomy and anoplasty for chronic anal fissure
Official title: Comparative Outcomes of Injection Botox Alone Versus Injection Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure
Run by Islamabad Medical and Dental College · NCT07665528 · Data updated 2026-11-12
This study tests whether adding fissurectomy and anoplasty to Botox injections helps healing and pain relief for adults with chronic anal fissure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Islamabad Medical and Dental College Academic / other |
| Locations | 1 site (Islamabad, Federal) |
| Status | Recruiting |
| Started | June 3, 2026 |
| Main results expected | September 3, 2026 |
| Study ends | December 3, 2026 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT07665528 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with chronic anal fissure (>6 weeks) who failed at least 6 weeks of conservative therapy and are fit for anesthesia.
✕Probably not a fit
Patients who do not respond to Botox or who experience complications may not benefit from the combined approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective study compares two treatments for chronic anal fissure: Botox injections alone versus Botox injections plus fissurectomy and anoplasty. Adults 18–65 with fissures persisting more than 6 weeks and failure of conservative therapy are eligible. The trial will measure healing rate, pain relief, time to healing, recurrence, continence, and patient satisfaction, with 108 participants divided into the two groups and followed post-treatment. Outcomes will help determine if adding a surgical component to Botox provides better results without unacceptable risk. The study is conducted at Islamabad Medical and Dental College in Islamabad.
Why it matters
Potential benefit: If successful, patients could experience higher healing rates and longer-lasting relief with an approach that addresses both sphincter spasm and tissue healing.
How similar studies have gone: Prior Botox therapy has shown variable healing; combining with fissurectomy/anoplasty is a newer approach with limited, although promising, evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Adults aged 18 to 65 years, regardless of sex Diagnosis of chronic anal fissure persisting for more than 6 weeks Failure of at least 6 weeks of standardized conservative treatment Fit for anesthesia and surgical intervention Willing and able to provide written informed consent Exclusion Criteria: Acute anal fissure Inflammatory bowel disease Anal malignancy Previous anal surgery Pregnancy Pre-existing fecal incontinence Immunocompromised patients
Where it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Ultrasound-based look at how much sphincter is cut during LIS for chronic anal fissure
This study tests whether the amount of internal anal sphincter divided during lateral internal sphincterotomy affects healing and continence in adults with chronic anal fissure.
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Improving recovery after surgery for benign anorectal conditions
This study is testing if a special recovery plan can help people aged 18 to 65 have fewer problems with urinary retention after surgery for conditions like hemorrhoids and anal fissures.
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AI-assisted written information to support treatment for chronic anal fissure
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Three LIS techniques for chronic anal fissure healing
This trial tests three different ways of performing lateral internal sphincterotomy to see which best heals chronic anal fissures with the least risk of incontinence.
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Combined surgical approach for chronic anal fissure
This trial tries removing the fissure and giving botulinum toxin A to relax the internal anal sphincter in people with chronic anal fissure to reduce pain, recurrence, and sphincter problems.
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Treatment for chronic anal fissures using E-CEL UVEC cells
This study is testing if injections of special cells can help people with chronic anal fissures who haven't found relief from regular treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.