Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLomonosov Moscow State University Medical Research and Educational Center
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Botulinum toxin type A
- Saline (0.9% NaCl)
Treatment groups
292 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov