Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain

Официальное название

Effect of Internal Anal Sphincter Botulinum Toxin A Injection 7 Days Before Hemorrhoidectomy on Postoperative Pain: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Botulinum toxin type A
  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.
• Препарат Saline (0.9% NaCl)
  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.

Первичные конечные точки

• Postoperative Pain Intensity Within the First 7 Days After Hemorrhoidectomy [Срок оценки: Postoperative days 1-7]

Вторичные конечные точки (8)

• Total opioid consumption within 72 hours postoperatively [Срок оценки: Within 72 hours after surgery (postoperative hours 0-72)]
• Length of hospital stay [Срок оценки: From day of surgery until hospital discharge (up to 30 days postoperatively)]
• Incidence of postoperative complications within 30 days [Срок оценки: Within 30 days after surgery]
• Transient fecal incontinence rates assessed by Wexner score [Срок оценки: Postoperative days 14 and 30]
• Readmission or unplanned medical visits within 30 days [Срок оценки: Within 30 days postoperatively]
• Pain during defecation assessed by VAS [Срок оценки: Postoperative days 1, 3, and 7]
• Time to first bowel movement [Срок оценки: From day of surgery until first bowel movement (up to hospital discharge, maximum 7 days)]
• Patient satisfaction score [Срок оценки: Postoperative day 30]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Россия · 1 центр

• Lomonosov Moscow State University Medical Research and Educational Center — Moscow

Публикации

• Lie H, Lukito PP, Sudirman T, Purnama AA, Sutedja R, Setiawan A, Jeo WS, Irawan A, Satriya W, Koerniawan HS, Hariyanto TI. Utility of botulinum toxin injection for post-operative pain management after conventional hemorrhoidectomy: a systematic review and meta-analysis of clinical trials. Scand J Gastroenterol. 2023 Feb;58(2):116-122. doi: 10.1080/00365521.2022.2116292. Epub 2022 Sep 1. PMID 36048469
• Patti R, Arcara M, Bonventre S, Sammartano S, Sparacello M, Vitello G, Di Vita G. Randomized clinical trial of botulinum toxin injection for pain relief in patients with thrombosed external haemorrhoids. Br J Surg. 2008 Nov;95(11):1339-43. doi: 10.1002/bjs.6236. PMID 18844269
• Jin J, Unasa H, Bahl P, Mauiliu-Wallis M, Svirskis D, Hill A. Can Targeting Sphincter Spasm Reduce Post-Haemorrhoidectomy Pain? A Systematic Review and Meta-Analysis. World J Surg. 2023 Feb;47(2):520-533. doi: 10.1007/s00268-022-06807-3. Epub 2022 Nov 10. PMID 36357803
• Quinn R, Jamsari G, Albayati S. Botulinum toxin injection for management of post-haemorrhoidectomy pain: an updated systematic review and meta-analysis of randomised clinical trials. Tech Coloproctol. 2025 Apr 7;29(1):96. doi: 10.1007/s10151-025-03137-z. PMID 40192825
• Sirikurnpiboon S, Jivapaisarnpong P. Botulinum Toxin Injection for Analgesic Effect after Hemorrhoidectomy: A Randomized Control Trial. J Anus Rectum Colon. 2020 Oct 29;4(4):186-192. doi: 10.23922/jarc.2020-027. eCollection 2020. PMID 33134600
• Yaghoobi Notash A, Sadeghian E, Heshmati A, Sorush A. Effectiveness of Local Botulinum Toxin Injection for Perianal Pain after Hemorrhoidectomy. Middle East J Dig Dis. 2022 Jul;14(3):330-334. doi: 10.34172/mejdd.2022.291. Epub 2022 Jul 30. PMID 36619264
• Patti R, Almasio PL, Muggeo VM, Buscemi S, Arcara M, Matranga S, Di Vita G. Improvement of wound healing after hemorrhoidectomy: a double-blind, randomized study of botulinum toxin injection. Dis Colon Rectum. 2005 Dec;48(12):2173-9. doi: 10.1007/s10350-005-0179-5. PMID 16400513
• Davies J, Duffy D, Boyt N, Aghahoseini A, Alexander D, Leveson S. Botulinum toxin (botox) reduces pain after hemorrhoidectomy: results of a double-blind, randomized study. Dis Colon Rectum. 2003 Aug;46(8):1097-102. doi: 10.1007/s10350-004-7286-6. PMID 12907905

Идентификаторы

NCT: NCT07399860 · BoTo-HEM RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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