Actively Recruiting
Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain
Led by Lomonosov Moscow State University Medical Research and Educational Center · Updated on 2026-03-10
292
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lomonosov Moscow State University Medical Research and Educational Center
Moscow, Moscow, Russia, 119991
Actively Recruiting
Research Team
T
Tatiana Garmanova, MD, PhD
CONTACT
A
Aleksandr Lukianov, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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