THE TREATMENT OF CHRONIC ANAL FISSURES WITH FISSURE EXCISION AND BOTULINUM TOXIN TYPE A INJECTION (ISRCTN97413456)

Abstract

AIM: to assess the efficacy of botulinum toxin type A for chronic anal fissure. PATIENTS AND METHODS: the study included 80 patients randomized by random number generation in 2 groups. Forty patients underwent fissure excision in combination with injections of botulinum toxin type A into the internal sphincter (main group) and 40 – in combination with pneumatic balloon dilatation of the anal sphincter (control group). RESULTS: there were no statistically significant differences in the intensity of postoperative pain after defecation and during the day between the groups, p=0.45 and p=0.39, respectively. The groups were comparable in the complications such as perianal skin hematomas (p=0.84), external hemorrhoid thrombosis (p=0.1), urinary retention (p=0.46), long-term non-healing wounds (p=0.76). Transitory weakening of the anal sphincter was significantly more often in the control group. On day 30, the transitory anal incontinence in the main group was detected in 6 (21%), in the control group – in 18 (75%) patients, p=0.0002. On day 60, the weakness of the anal sphincter remained in the main group in 3 (10.7%), in the control group – in 10 (41%) patients, p=0.02. CONCLUSION: botulinum toxin type A and pneumatic balloon dilatation have equal effectiveness in the treatment of chronic anal fissure. The use of botulinum toxin type A can reduce the incidence of transitory weakening of the anal sphincter function in patients with chronic anal fissure.