Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain

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.

NCT Number	NCT07399860
Lead Sponsor	Lomonosov Moscow State University Medical Research and Educational Center
Conditions	Hemorrhoids, Postoperative Pain
Enrollment	292 participants
Start Date	2026-02-01
Primary Completion	2027-01 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-10