Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain

Summary

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.

Timeline

Start

2026-02-01

Primary completion

2027-01

Completion

2028-01

Publications

• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.

Drugs

Indications