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NCT Number: NCT07399860

Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: botox, BTX-A

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.

Primary outcomes

  1. Postoperative Pain Intensity Within the First 7 Days After Hemorrhoidectomy

    Time frame: Postoperative days 1-7

    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.

Secondary outcomes

  1. Total opioid consumption within 72 hours postoperatively

    Time frame: Within 72 hours after surgery (postoperative hours 0-72)

    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.

  2. Length of hospital stay

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

    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.

  3. Incidence of postoperative complications within 30 days

    Time frame: Within 30 days after surgery

    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.

  4. Transient fecal incontinence rates assessed by Wexner score

    Time frame: Postoperative days 14 and 30

    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.

  5. Readmission or unplanned medical visits within 30 days

    Time frame: Within 30 days postoperatively

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

  6. Pain during defecation assessed by VAS

    Time frame: Postoperative days 1, 3, and 7

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

  7. Time to first bowel movement

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

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

  8. Patient satisfaction score

    Time frame: Postoperative day 30

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksandr Lukianov, MD

CONTACT

[email protected]

+ 7 916 772 93 03

Tatiana Garmanova, MD, PhD

CONTACT

[email protected]

+ 7 977 342 92 49

Sponsors and collaborators

Lead sponsor

Lomonosov Moscow State University Medical Research and Educational Center

Other

Registry information

Official study title

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

Acronym: BoTo-HEM

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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