Effectiveness of Local Botulinum Toxin Injection for Perianal Pain after Hemorrhoidectomy.
Aidin Yaghoobi Notash, Ehsan Sadeghian, Alireza Heshmati...
https://pubmed.ncbi.nlm.nih.gov/36619264/Actively Recruiting
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
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
Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain
T
Tatiana Garmanova, MD, PhD
A
Aleksandr Lukianov, MD
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Lomonosov Moscow State University Medical Research and Educational Center
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants receive a single preoperative injection of either botulinum toxin type A or placebo into the internal anal sphincter seven days prior to hemorrhoidectomy.
1 visit (in-person) for injection
Duration - Day of surgery
Participants undergo open or closed excisional hemorrhoidectomy using standardized surgical and perioperative care protocols.
1 surgery visit (in-person)
Duration - Up to 30 days
Participants are monitored for postoperative pain, analgesic use, complications, bowel movements, and patient satisfaction for up to 30 days after surgery.
Daily visits or assessments during first 7 days, plus visits on days 14 and 30
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Lead Sponsor