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New treatment option for Hemorrhoids
Official title Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain
ClinicalTrials.gov ID: NCT07399860
What this study is testing
What is Botulinum toxin type A?
Botulinum toxin type A is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hemorrhoids.
Also referred to as botox, BTX-A.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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.
See the full eligibility 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
- 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 treatment clinical trial within 30 days.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Moscow, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.