+1 877 705 191424 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07399860

Study of Botulinum Toxin A Injection Before Hemorrhoid Surgery to Reduce Postoperative Pain

Led by Lomonosov Moscow State University Medical Research and Educational Center · Updated on 2026-03-10

292

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying adults with advanced hemorrhoidal disease grade III-IV to see if injecting botulinum toxin type A into the internal anal sphincter one week before hemorrhoidectomy can reduce pain after surgery. This is a randomized, double-blind, placebo-controlled clinical trial comparing botulinum toxin A injection with saline injection. The trial aims to understand if relaxing the sphincter before surgery improves recovery and reduces pain. Participants will be randomly assigned to receive either botulinum toxin type A or a saline injection into the internal anal sphincter seven days before their hemorrhoidectomy surgery. The injection is given in four specific areas using a standardized method. After the injection, all participants will have open or closed hemorrhoidectomy with standard surgical care. The study ensures neither patients nor surgeons know which injection was given. During the first week after surgery, researchers will assess pain levels using a visual scale and track opioid use, complications, hospital stay length, bowel function, and patient satisfaction over 30 days. Additional evaluations include fecal incontinence rates, time to first bowel movement, and any unplanned medical visits. The study will monitor recovery closely up to 30 days after surgery to understand the impact of the treatment.

CONDITIONS

Brief Title

Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain

Research Team

T

Tatiana Garmanova, MD, PhD

A

Aleksandr Lukianov, MD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here