Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain

NCT07399860 | Recruiting Phase 2

• 1 other identifier: BoTo-HEM RCT
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemorrhoids; Postoperative Pain

Keywords

Hemorrhoidectomy; Botulinum toxin; Postoperative pain; Anal sphincter spasm

Outcome Measures

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.

  Postoperative days 1-7

Secondary Outcomes (8)

• Total opioid consumption within 72 hours postoperatively

  Within 72 hours after surgery (postoperative hours 0-72)

• Length of hospital stay

  From day of surgery until hospital discharge (up to 30 days postoperatively)

• Incidence of postoperative complications within 30 days

  Within 30 days after surgery

• Transient fecal incontinence rates assessed by Wexner score

  Postoperative days 14 and 30

• Readmission or unplanned medical visits within 30 days

  Within 30 days postoperatively

Study Arms (2)

Preoperative Botulinum Toxin A Injection

EXPERIMENTAL

Participants receive a preoperative injection of botulinum toxin type A into the internal anal sphincter seven days prior to excisional hemorrhoidectomy, in addition to standard surgical treatment.

Drug: Botulinum toxin type A

Preoperative Placebo Injection

PLACEBO COMPARATOR

Participants receive a preoperative injection of normal saline into the internal anal sphincter seven days prior to excisional hemorrhoidectomy, in addition to standard surgical treatment.

Drug: Saline (0.9% NaCl)

Interventions

Botulinum toxin type A DRUG

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.

Also known as: botox, BTX-A

Preoperative Botulinum Toxin A Injection

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.

Preoperative Placebo Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lomonosov Moscow State University Medical Research and Educational Center: lead

Study Sites (1)

Lomonosov Moscow State University Medical Research and Educational Center

Moscow, Moscow, 119991, Russia

RECRUITING

Related Publications (8)

• 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 RESULT

• 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 RESULT

• Jin, J., Unasa, H., Bahl, P. et al. Can Targeting Sphincter Spasm Reduce Post-Haemorrhoidectomy Pain? A Systematic Review and Meta-Analysis. World J Surg 47, 520-533 (2023). https://doi.org/10.1007/s00268-022-06807-3

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tatiana Garmanova, MD, PhD

  Lomonosov Moscow State University Medical Research and Educational Center

  STUDY DIRECTOR

Central Study Contacts

Tatiana Garmanova, MD, PhD

CONTACT

+ 7 977 342 92 49; tatianagarmanova@gmail.com

Aleksandr Lukianov, MD

CONTACT

+ 7 916 772 93 03; alexmaxl1225469@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 10, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)