Treatment of chronic anal fissure botulinum toxin type A 40 U in comparison with lateral subcutaneous sphincterotomy (NCT03855046)

AIM: to improve the results of chronic anal fissure treatment.PATIENTS AND METHODS: prospective randomized study included 176 patients divided in two groups. Eighty-eight underwent excision combination with injection botulinum toxin type A (incobotulinum toxin) into internal sphincter (main group, BTA), and 88 lateral subcutaneous sphincterotomy (control LIS).RESULTS: on 30th day after surgery, spasm sphincter, according profilometry, persisted 14.8% main group (BTA) 22.7% control (LSS) (p = 0.18), 60th 20.4% patients, respectively 0.32). On postoperative wound did not epithelialize 14% BTA 1% LSS 0.0006). complaints incontinence were noted by 32% 31% 0.87), — 7% 11% 0.29). The intensity pain surgery compared groups differ both defecation during > 0.05). Expansion volume increases chance developing temporary (ASI) 2.44 times observation 0.01) 3 60 0.04). use as a method relaxation slowing down epithelization 13.7 [p 0.01], expansion 3.47 0.03].CONCLUSION: 40 U is inferior elimination comparable incidence within 2 months surgery. Neurotoxin serves an alternative sphincterotomy, however, some cases, it requires addition agent containing human recombinant epidermal growth factor management patients.