Treatment of chronic anal fissure botulinum toxin type A 40 U in comparison with lateral subcutaneous sphincterotomy (NCT03855046)
R. Yu. Khryukin, Е. Е. Жарков, N. A. Goloktionov, S. V. Nekhrikova, Vladimir Yurevich Medvedev, Sergej Valerevich Slozhenikin, E. A. Zagryadskii, А. А. Пономаренко
Abstract
AIM: to improve the results of chronic anal fissure treatment.PATIENTS AND METHODS: the prospective randomized study included 176 patients divided in two groups. Eighty-eight patients underwent fissure excision in combination with injection of botulinum toxin type A (incobotulinum toxin) into the internal anal sphincter (main group, BTA), and 88 patients underwent anal fissure excision in combination with lateral subcutaneous sphincterotomy (control group, LIS).RESULTS: on the 30th day after surgery, spasm of internal anal sphincter, according to profilometry, persisted in 14.8% of patients of the main group (BTA) and 22.7% of patients in the control group (LSS) (p = 0.18), and on the 60th day in 20.4% and 14.8% of patients, respectively (p = 0.32). On the 60th day after surgery, the postoperative wound did not epithelialize in 14% of patients in the BTA group and 1% of the LSS group (p = 0.0006). On the 30th day after surgery, complaints of incontinence were noted by 32% of patients in the BTA group and 31% in the LSS group (p = 0.87), on the 60th day — 7% and 11% of patients, respectively (p = 0.29). The intensity of pain after surgery in the compared groups did not differ both after defecation and during the day (p > 0.05). Expansion of the surgery volume increases the chance of developing temporary anal sphincter incontinence (ASI) by 2.44 times on the 30th day of observation (p = 0.01) and by 3 times — on day 60 (p = 0.04). The use of BTA as a method of internal anal sphincter relaxation increases the chance of slowing down the epithelization of the postoperative wound by 13.7 times [p = 0.01], and the expansion of the surgery volume — by 3.47 times [p = 0.03].CONCLUSION: the use 40 U of botulinum toxin type A after anal fissure excision is not inferior to lateral subcutaneous sphincterotomy in elimination of spasm internal anal sphincter with a comparable incidence of temporary anal sphincter incontinence within 2 months after surgery. Neurotoxin serves as an alternative to sphincterotomy, however, in some cases, it requires the addition of a agent containing human recombinant epidermal growth factor to the postoperative management of patients.