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Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain

RecruitingPhase 2Ages 18 Years - anyAllLomonosov Moscow State University Medical Researc…
NCT07399860 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Hemorrhoidectomy is an effective surgical treatment for advanced hemorrhoidal disease but is often associated with significant postoperative pain, which may delay recovery. One of the main contributors to pain after hemorrhoidectomy is spasm and increased tone of the internal anal sphincter. This randomized, double-blind, placebo-controlled clinical trial evaluates whether preoperative injection of botulinum toxin type A into the internal anal sphincter, performed seven days before hemorrhoidectomy, can reduce postoperative pain compared with placebo. Adult patients with grade III-IV hemorrhoids scheduled for excisional hemorrhoidectomy will be randomized to receive either botulinum toxin A or saline injection prior to surgery. Postoperative pain intensity, analgesic consumption, complications, functional outcomes, and patient satisfaction will be assessed during the first 30 days afte

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults ≥18 years, male and female * Symptomatic grade III-IV hemorrhoidal disease (Goligher), refractory to conservative treatment * Scheduled for open (Milligan-Morgan) or closed (Ferguson) hemorrhoidectomy Exclusion Criteria: * Known hypersensitivity to botulinum toxin A, human albumin, or local anesthetics. * Neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome). * Use of aminoglycosides or other agents interfering with neuromuscular transmission within 14 days. * Coagulopathy or ongoing anticoagulant therapy not suitable for perioperative interruption. * Active anorectal infection, fissure, abscess, or inflammatory bowel disease in the active phase. * Previous anal sphincter surgery or baseline fecal incontinence. * Pregnancy or breastfeeding. * ASA ≥ III or significant systemic disease compromising anesthesia or wound healing. * Participation in another interventional clinical trial within 30 days.
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What it tests

  • Botulinum toxin type A
  • Saline (0.9% NaCl)
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Where

1 site
Lomonosov Moscow State University Medical Research and Educational Center
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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