Botulinum Toxin A for Hemorrhoid Pain Relief
Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain
Recruiting
Phase 2
Interventional Study
Hemorrhoids
Postoperative Pain
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 292 (estimated)
- Sponsor
- Lomonosov Moscow State University Medical Research and Educational Center · Other
Who this trial is looking for
This trial is looking for adults with severe hemorrhoids who are scheduled for surgery. Participants will receive an injection before surgery to see if it helps reduce pain afterward.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have been diagnosed with grade III or IV hemorrhoids.
- I have not had success with other treatments.
- I am scheduled for hemorrhoid surgery.
You may not be able to join if
- I am allergic to botulinum toxin A or local anesthetics.
- I have a neuromuscular disorder.
- I have taken certain medications in the last 14 days.
- I have a bleeding disorder or cannot stop blood thinners.
- I have an active anorectal infection or inflammatory bowel disease.
- I have previously had anal sphincter surgery.
- I am pregnant or breastfeeding.
- I have significant health issues affecting anesthesia.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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About This Trial
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 …
Trial Locations
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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, …
Contacts