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.
Research Square (Research Square)(2023)
摘要
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.
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关键词
chronic anal fissure,botulinum toxin injection,botulinum toxin,treatment,first-line
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