Surgical Treatment Combining Excision and Botulinum Toxin for Chronic Anal Fissure Reducing Sphincter Spasm and Improving Recovery

What this Trial Is About

Researchers are evaluating treatment options for patients with chronic anal fissure, a painful rupture of the anal canal mucous membrane lasting over two months and resistant to non-surgical treatments. This condition mainly affects young and able-bodied adults and is caused by spasms of the internal anal sphincter muscle. The study aims to improve treatment outcomes by reducing the frequency and duration of anal sphincter insufficiency after relieving these spasms. Participants will undergo excision of the anal fissure combined with relaxation of the internal sphincter using botulinum toxin type A. The treatment involves injecting 40 units of botulinum toxin into the internal anal sphincter at four specific locations. The study compares this combined approach to similar treatment methods and includes an additional injection of platelet-rich plasma. Patients are randomized into either the main group or control group, both receiving the same interventions. During the trial, researchers will monitor anal sphincter insufficiency over 60 days as the primary outcome. Secondary outcomes include pain intensity, wound healing, sphincter function measurements, temporary disability, and disease relapse, assessed at various intervals up to one year. Participants will be closely observed throughout these periods with clinical evaluations to track treatment effects and safety.

Combined Method of Surgical Treatment of Anal Fissure