Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain

Phase 2Not Yet RecruitingNCT07399860

Lomonosov Moscow State University Medical Research and Educational Center292 enrolled

Overview

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.

This multicenter, randomized, double-blind, placebo-controlled trial is designed to investigate the effect of preoperative botulinum toxin type A injection into the internal anal sphincter on postoperative pain following excisional hemorrhoidectomy. Eligible adult patients with symptomatic grade III-IV hemorrhoids will be randomized in a 1:1 ratio to receive either botulinum toxin type A or placebo injection seven days prior to surgery. Botulinum toxin A will be injected into the internal anal sphincter in four quadrants using a standardized technique, while the control group will receive an identical volume of normal saline. Both patients and surgeons performing hemorrhoidectomy, as well as outcome assessors, will be blinded to treatment allocation. All participants will subsequently undergo open or closed hemorrhoidectomy using standardized surgical and perioperative care protocols. Postoperative pain will be assessed using a visual analogue scale during the first seven postoperative days. Secondary outcomes include analgesic consumption, postoperative complications, length of hospital stay, transient fecal incontinence, time to first bowel movement, readmissions, and patient-reported satisfaction within 30 days after surgery. The study aims to determine whether preoperative chemical sphincter relaxation with botulinum toxin A can improve postoperative recovery and reduce pain following hemorrhoidectomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

Botulinum toxin type ADRUG

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.

Saline (0.9% NaCl)DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Outcomes

Primary Outcomes

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 1-7

Secondary Outcomes

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)

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)

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 surgery

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 30

Readmission or unplanned medical visits within 30 days

Hospital readmission or unplanned medical visits occurring within 30 days after surgery, compared between the botulinum toxin type A group and the placebo group.

Time frame: Within 30 days postoperatively

Pain during defecation assessed by VAS

Pain intensity during defecation assessed using the Visual Analog Scale (VAS) and compared between the botulinum toxin type A group and the placebo group.

Time frame: Postoperative days 1, 3, and 7

Time to first bowel movement

Time to first bowel movement measured in hours and compared between the botulinum toxin type A group and the placebo group.

Time frame: From day of surgery until first bowel movement (up to hospital discharge, maximum 7 days)

Patient satisfaction score

Patient satisfaction assessed using a numeric rating scale from 0 to 10, where higher scores indicate greater satisfaction. Scores are compared between the botulinum toxin type A group and the placebo group.

Time frame: Postoperative day 30