Combined surgical approach for chronic anal fissure
Combined Method of Surgical Treatment of 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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | State Scientific Centre of Coloproctology, Russian Federation Government |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07268261 on ClinicalTrials.gov |
What this trial studies
This single-center interventional program tests a combined surgical approach for chronic anal fissure that pairs fissure excision with postoperative injection of botulinum toxin A to relax the internal anal sphincter. The rationale is that sphincter spasm underlies chronic fissures and that botulinum toxin may reduce postoperative sphincter hypertonia, lowering pain and the risk or duration of sphincter insufficiency. Participants are adults with chronic fissures and internal sphincter spasm who meet exclusion criteria such as inflammatory bowel disease, prior anal surgery, significant sphincter insufficiency, pregnancy, or contraindications to botulinum toxin. The study is conducted at the State Scientific Centre of Coloproctology in Moscow and uses surgical excision followed by botulinum toxin as the interventional protocol; outcomes likely include pain, healing, recurrence, and incontinence though specific endpoints are not listed in the registry entry.
Who should consider this trial
Good fit: Adults with chronic anal fissure lasting more than two months with documented internal sphincter spasm and without exclusion conditions such as inflammatory bowel disease, prior anal canal surgery, significant sphincter insufficiency, pregnancy, or contraindications to botulinum toxin are ideal candidates.
Not a fit: Patients with active inflammatory bowel disease, existing anal sphincter insufficiency, prior anal surgeries, pregnancy, lactation, or known hypersensitivity to botulinum toxin are unlikely to be eligible or to receive benefit.
Why it matters
Potential benefit: If successful, this approach could speed healing and reduce postoperative pain, recurrence, and the frequency or duration of sphincter-related incontinence.
How similar studies have performed: Botulinum toxin A has been used with modest success as a non-surgical treatment for chronic anal fissure, but combining fissure excision with immediate botulinum injection is less extensively studied and is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Patients with chronic anal fissure with spasm of anal sphincter Exclusion Criteria: * • Inflammatory diseases of the colon * Pectenosis * Previous surgical interventions on the anal canal * IV grade internal and external hemorrhoids * Rectal fistula * Severe somatic diseases at the decompensation stage * Pregnancy and lactation * Anal sphincter insufficiency * Chronic paraproctitis * Individual intolerance and hypersensitivity to botulinum toxin * Myasthenia gravis and myasthenic syndromes * History of allergic reaction to anticoagulants. * Blood diseases (thrombocytopenia, splenomegaly, etc.)
Where this trial is running
Moscow
- SSCCRussia — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Sergey A. Frolov, Ph.D — State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)
- Study coordinator: Evgeny E. Zharkov, MD
- Email: drzharkov@mail.ru
- Phone: +79039689739
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.