Effect of Internal Anal Sphincter Botulinum Toxin A Injection 7 Days Before Hemorrhoidectomy on Postoperative Pain: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

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.

Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain