Simona Ascanelli, Eleonora Rossin, Filippo Aisoni, Elisabetta Sette, Laura Chimisso, Giorgia Valpiani, Anna Costanzini, Roberto DE Giorgio, Carlo V Feo
{"title":"Botulinum toxin injection for chronic anal fissure: a prospective controlled study with long follow-up.","authors":"Simona Ascanelli, Eleonora Rossin, Filippo Aisoni, Elisabetta Sette, Laura Chimisso, Giorgia Valpiani, Anna Costanzini, Roberto DE Giorgio, Carlo V Feo","doi":"10.23736/S2724-5691.24.10228-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Botulinum toxin is an effective therapeutic option for chronic anal fissure. However, there is no evidence about treatment standardization and long-term follow-up. We aimed to evaluate the short- and long-term efficacy and safety of botulinum toxin compared to close lateral internal sphincterotomy, with a 5-year follow-up.</p><p><strong>Methods: </strong>This was a prospective, controlled, single-center study conducted at University Hospital of Ferrara, Ferrara, Italy. The primary outcome was fissure healing at 1 month. Secondary outcomes were Quality-of-Life (QoL) at 1 month and after 5 years, and fissure recurrence at 6 months and 5 years.</p><p><strong>Results: </strong>A total of 59 patients received botulinum toxin injection (Botox), and 32 underwent lateral internal sphincterotomy. At 1 month after treatments, postoperative pain decreased faster and significantly more in the Botox group (30 vs. 60 mm; P<0.001); fissure re-epithelization was observed in 59.4% of the surgical group compared to 25.4% of Botox (P=0.0001). Anal sphincter pressures decreased more in surgical group (P=0.044), although severe anal incontinence was present only in this subset (6.2%; P=0.041). Compared to surgery, patients who received Botox had higher satisfaction rates (P<0.001). Fissure recurrence at 6 months was more common in Botox than surgical group (16.9% vs. 3.2%, respectively; P=0.053). The overall healing rate improved in all patients and persisted at 12 months and 5 years in both groups with overall high patient satisfaction despite mild anal incontinence in 21.8% in the surgery group (P<0.05).</p><p><strong>Conclusions: </strong>Botox, rather than surgery, should be considered the first-line treatment for chronic anal fissure.</p>","PeriodicalId":29847,"journal":{"name":"Minerva Surgery","volume":null,"pages":null},"PeriodicalIF":1.8000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Minerva Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.23736/S2724-5691.24.10228-6","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/3/29 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Botulinum toxin is an effective therapeutic option for chronic anal fissure. However, there is no evidence about treatment standardization and long-term follow-up. We aimed to evaluate the short- and long-term efficacy and safety of botulinum toxin compared to close lateral internal sphincterotomy, with a 5-year follow-up.
Methods: This was a prospective, controlled, single-center study conducted at University Hospital of Ferrara, Ferrara, Italy. The primary outcome was fissure healing at 1 month. Secondary outcomes were Quality-of-Life (QoL) at 1 month and after 5 years, and fissure recurrence at 6 months and 5 years.
Results: A total of 59 patients received botulinum toxin injection (Botox), and 32 underwent lateral internal sphincterotomy. At 1 month after treatments, postoperative pain decreased faster and significantly more in the Botox group (30 vs. 60 mm; P<0.001); fissure re-epithelization was observed in 59.4% of the surgical group compared to 25.4% of Botox (P=0.0001). Anal sphincter pressures decreased more in surgical group (P=0.044), although severe anal incontinence was present only in this subset (6.2%; P=0.041). Compared to surgery, patients who received Botox had higher satisfaction rates (P<0.001). Fissure recurrence at 6 months was more common in Botox than surgical group (16.9% vs. 3.2%, respectively; P=0.053). The overall healing rate improved in all patients and persisted at 12 months and 5 years in both groups with overall high patient satisfaction despite mild anal incontinence in 21.8% in the surgery group (P<0.05).
Conclusions: Botox, rather than surgery, should be considered the first-line treatment for chronic anal fissure.