Can Botulinum Toxin Injection be considered a First-Line Treatment for the Management of Chronic Anal Fissure? A Prospective Controlled Study with 5-years Follow-up.

Abstract

Abstract Purpose Botulinum Toxin effectiveness for treatment of chronic anal fissure has been widely proven, but there is lack of evidence about treatment standardization and long-term follow-up. The purpose of this study was to evaluate the short- and long-term efficacy and safety of Botulinum Toxin treatment compared with close lateral internal sphincterotomy, with 5-years follow-up. Methods This was a prospective, case-control, single-center study conducted at Ferrara University Hospital, Italy. The primary outcome was fissure healing at 1 month. Results 59 patients received the Botulinum Toxin injection, and 32 patients underwent lateral internal sphincterotomy. At 1 month after treatments postoperative pain decreased faster and significantly more in the Botox group (30 mm vs 60 mm, p < 0.001); fissure re-epithelization was observed in 59.4% of surgical group compared to 25.4% in Botox group (p = 0.0001); anal sphincter pressures decreased more in surgical group (p = 0.044) and severe anal incontinence was present only in surgical group (6.2% of patients, p = 0.041). Patient satisfaction was better in Botox group (p < 0.001). Adverse Events occurred more frequently in surgical group (46.9% vs 8.5%, p < 0.001). Fissure recurrence at 6 months was observed in 16.9% of patients in Botox group vs 3.2% in surgical group (p = 0.053). At 12 months the overall healing rate improved to 100% in the two groups persisting in all patients in both groups after 5 years with high patient satisfaction despite the presence of mild anal incontinence in 21.8% of patients of surgical group (p < 0.05). Conclusion Botox injection can be considered as a first-line treatment for chronic anal fissure.