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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Botulinum toxin type A
DrugParticipants 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.
Saline (0.9% NaCl)
DrugParticipants 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.
Treatment groups
292 Participants
are divided into 2 treatment groupsGroup A: Preoperative Botulinum Toxin A InjectionExperimental treatment 1 intervention
Group B: Preoperative Placebo InjectionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Pain Intensity Within the First 7 Days After Hemorrhoidectomy
Postoperative pain intensity assessed using a 100-mm visual analogue scale (VAS). Daily pain scores are recorded and used to calculate the area under the curve (AUC) over postoperative days 1-7 for comparison between study groups.
Time frame
Postoperative days 1-7Secondary outcomes
1
Total opioid consumption within 72 hours postoperatively
Total postoperative opioid consumption expressed in morphine equivalents (mg) measured within the first 72 hours after surgery. Opioid use is recorded and compared between the botulinum toxin type A group and the placebo group.
Time frame
Within 72 hours after surgery (postoperative hours 0-72)2
Length of hospital stay
Length of postoperative hospital stay measured in days, calculated from the day of surgery to the day of hospital discharge, and compared between the botulinum toxin type A group and the placebo group.
Time frame
From day of surgery until hospital discharge (up to 30 days postoperatively)3
Incidence of postoperative complications within 30 days
Incidence of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo classification, and compared between the botulinum toxin type A group and the placebo group.
Time frame
Within 30 days after surgery4
Transient fecal incontinence rates assessed by Wexner score
Transient fecal incontinence assessed using the Wexner score to evaluate severity and frequency of symptoms, and compared between the botulinum toxin type A group and the placebo group.
Time frame
Postoperative days 14 and 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov