Botulinum toxin A injection before hemorrhoid surgery to reduce postoperative pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial gives adult patients with symptomatic grade III–IV hemorrhoids either botulinum toxin A or saline injected into the internal anal sphincter seven days before excisional hemorrhoidectomy. Injections are performed in four quadrants using a standardized technique and both patients and surgeons are blinded to allocation. All participants undergo open or closed hemorrhoidectomy with standardized perioperative care, and postoperative pain is measured with a visual analogue scale during the first seven days. Secondary outcomes include analgesic use, complications, length of stay, transient fecal incontinence, time to first bowel movement, readmissions, and patient satisfaction within 30 days.

Why it matters

Who can join: the full rules

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.

Where it's running

• Lomonosov Moscow State University Medical Research and Educational Center
  Moscow, Moscow, Russia Recruiting

Study contacts

• Study coordinator: Tatiana Garmanova, MD, PhD
• Email: tatianagarmanova@gmail.com
• Phone: + 7 977 342 92 49

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.