Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Hemorrhoids, Postoperative Pain

In brief

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 after surgery.

Key facts

Study ID

NCT07399860

Run by

Lomonosov Moscow State University Medical Research and Educational Center

People needed

292

Starts

2026-02-01

Expected to finish

2028-01-01

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Lomonosov Moscow State University Medical Research and Educational Center — Moscow, Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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