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Botox before hemorrhoid surgery may ease pain

NCT ID NCT07399860

Symptom relief Sponsor: Lomonosov Moscow State University Medical Research and Educational Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether injecting botulinum toxin (Botox) into the anal muscle one week before hemorrhoid removal surgery can lower pain after the operation. About 292 adults with severe hemorrhoids will get either Botox or a placebo injection before surgery. Researchers will track pain levels, painkiller use, and recovery for 30 days after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 292 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hemorrhoid Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemorrhoids Postoperative pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lomonosov Moscow State University Medical Research and Educational Center

    RECRUITING

    Moscow, Moscow, 119991, Russia

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