BACKGROUND: The aim of this prospective randomized trial was to compare the effectiveness and morbidity of surgical versus chemical sphincterotomy in the treatment of chronic anal fissure after a 3-year follow-up. METHODS:Eighty patients with chronic anal fissure were treated by whether open lateral internal sphincterotomy (group 1) or chemical sphincterotomy with 25 U botulinum toxin injected into the internal sphincter (group 2). Clinical and manometric results were analyzed. RESULTS:Overall healing was 92.5% in the open sphincterotomy group and 45% in the toxin botulinum group (P<.001). There is a group of patients with clinical (duration of disease >12 months and presence of a sentinel pile before treatment) and manometric factors (persistently elevated mean resting pressure, % of time presence of slow waves, and number of patients or the time presence ultra slow waves after treatment) associated with a higher recurrence of anal fissure. The final percentage of incontinence was 5% in the open sphincterotomy group and 0% in the botulinum toxin group (P>.05). CONCLUSION: We recommend surgical sphincterotomy as the first therapeutic approach in patients with clinical and manometric factors of recurrence. We prefer the use of botulinum toxin in patients older than 50 years or with risk factors for incontinence, despite the higher rate of recurrence, since it avoids the greater risk of incontinence in the surgical group.
RCT Entities:
BACKGROUND: The aim of this prospective randomized trial was to compare the effectiveness and morbidity of surgical versus chemical sphincterotomy in the treatment of chronic anal fissure after a 3-year follow-up. METHODS: Eighty patients with chronic anal fissure were treated by whether open lateral internal sphincterotomy (group 1) or chemical sphincterotomy with 25 U botulinum toxin injected into the internal sphincter (group 2). Clinical and manometric results were analyzed. RESULTS: Overall healing was 92.5% in the open sphincterotomy group and 45% in the toxin botulinum group (P<.001). There is a group of patients with clinical (duration of disease >12 months and presence of a sentinel pile before treatment) and manometric factors (persistently elevated mean resting pressure, % of time presence of slow waves, and number of patients or the time presence ultra slow waves after treatment) associated with a higher recurrence of anal fissure. The final percentage of incontinence was 5% in the open sphincterotomy group and 0% in the botulinum toxin group (P>.05). CONCLUSION: We recommend surgical sphincterotomy as the first therapeutic approach in patients with clinical and manometric factors of recurrence. We prefer the use of botulinum toxin in patients older than 50 years or with risk factors for incontinence, despite the higher rate of recurrence, since it avoids the greater risk of incontinence in the surgical group.
Authors: Pierpaolo Sileri; Alessandra Mele; Vito M Stolfi; Michele Grande; Giuseppe Sica; Paolo Gentileschi; Sara Di Carlo; Achille L Gaspari Journal: J Gastrointest Surg Date: 2007-08-31 Impact factor: 3.452