RecruitingPhase 2NCT07399860

Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain

Effect of Internal Anal Sphincter Botulinum Toxin A Injection 7 Days Before Hemorrhoidectomy on Postoperative Pain: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Sponsor

Lomonosov Moscow State University Medical Research and Educational Center

Enrollment

292 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain Hemorrhoids

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria9

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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Interventions

DRUGBotulinum toxin type A

Participants receive a single preoperative injection of botulinum toxin type A into the internal anal sphincter. The injection is administered seven days prior to excisional hemorrhoidectomy. Botulinum toxin type A is injected in divided doses at predefined points of the internal anal sphincter using standard technique. The intervention is performed once and no repeat injections are planned.

DRUGSaline (0.9% NaCl)

Participants receive a single preoperative injection of normal saline into the internal anal sphincter. The injection is administered seven days prior to excisional hemorrhoidectomy. Normal saline is injected in divided doses at the same predefined points and using the same technique and injection volume as in the experimental group. The intervention is performed once, with no repeat injections planned.