A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure

What this Trial Is About

Researchers are evaluating the efficacy and safety of treating chronic anal fissure, a painful rupture in the anal canal lasting over two months and resistant to non-surgical treatments. The study compares two treatment approaches: botulinum toxin injections and lateral subcutaneous sphincterotomy surgery. The condition mainly affects younger and working-age adults and involves internal sphincter muscle spasm as a key factor. One treatment group receives complex therapy including surgical removal of the fissure without cutting the internal sphincter, followed by injections of Botulinum Toxin Type A directly into the internal anal sphincter at four points. The other group undergoes lateral subcutaneous sphincterotomy, where the internal sphincter muscle is partially cut using a scalpel under anesthesia. Both procedures are performed under spinal anesthesia in a surgical setting. Participants will be monitored for up to 60 days after treatment. Researchers will assess anal sphincter insufficiency, pain intensity at multiple time points, wound healing, sphincter muscle function, temporary disability, and recurrence of the fissure. The study aims to understand differences in treatment effects, including frequency and duration of post-operative incontinence, by comparing these two approaches for chronic anal fissure.

Complex Treatment of a Chronic Anal Fissure