Botox or botox plus surgery: which heals anal fissures better?
NCT ID NCT07665528
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two treatments for chronic anal fissure, a painful tear in the anal canal. One group gets Botox injections alone to relax the muscle, while the other gets Botox plus a minor surgery to remove scar tissue and repair the area. Researchers will track healing, pain, and recurrence in 108 adults over several weeks to see which approach works best.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Botulinum toxin type A (Botox) injection, with or without fissurectomy and anoplasty surgery
- What this could lead to
- If the combined approach works better, it could offer a more effective, sphincter-preserving treatment for chronic anal fissure with lower recurrence.
- What could go wrong
- This is a small, early-stage trial with only 108 participants, so results may not apply to everyone. The added surgery also carries risks like infection or incontinence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Islamabad Medical and Dental College
RECRUITINGIslamabad, Federal, 44000, Pakistan
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