NCT07399860 Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain
| NCT ID | NCT07399860 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Lomonosov Moscow State University Medical Research and Educational Center |
| Condition | Hemorrhoids |
| Study Type | INTERVENTIONAL |
| Enrollment | 292 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 292 participants in total. It began in 2026-02-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Tatiana Garmanova, MD, PhD
STUDY DIRECTOR
Lomonosov Moscow State University Medical Research and Educational Center
Frequently Asked Questions
Who can join the NCT07399860 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemorrhoids. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07399860 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07399860 currently recruiting?
Yes, NCT07399860 is actively recruiting participants. Contact the research team at tatianagarmanova@gmail.com for enrollment information.
Where is the NCT07399860 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07399860 clinical trial?
NCT07399860 is sponsored by Lomonosov Moscow State University Medical Research and Educational Center. The principal investigator is Tatiana Garmanova, MD, PhD at Lomonosov Moscow State University Medical Research and Educational Center. The trial plans to enroll 292 participants.