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

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.

1. Renzi A, Izzo D, Di Sarno G. et al. Clinical, manometric, and ultrasonographic results of pneumatic balloon dilatation vs. lateral internal sphincterotomy for chronic anal fissure: a prospective, randomized, controlled trial. Dis Colon Rectum. 2008;51(1):121-127.

2. Nasr M, Ezzat H, Elsebae M. Botulinum toxin injection versus lateral internal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial. World J Surg. 2010;34(11):2730-2734.

3. Valizadeh N, Jalaly NY, Hassanzadeh M. et al. Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial. Langenbecks Arch Surg. 2012;397(7):1093-1098.

4. Magdy A, Nakeeb A, Fouda Y. et al. Comparative study of conventional lateral internal sphincterotomy, V-Y anoplasty, and tailored lateral internal sphincterotomy with V-Y anoplasty in the treatment of chronic anal fissure. J Gastrointest Surg. 2012;16(10):1955-1962.

5. Katsinelos P, Papaziogas B, Koutelidakis I. et al. Topical 0.5% nifedipine vs. lateral internal sphincterotomy for the treatment of chronic anal fissure: long-term follow-up. Int J Colorectal Dis. 2006;21(2):179-183.

6. Sohn N, Elsenberg MM, Weinstein MA. et al. Precise anorectal sphincter dilatation – its role in the therapy of anal fissures. Dis Colon Rectum. 1992;35(4):322-327.

7. Li L, Zhang JZ, Lu GW. et al. Damaging effects of anal stretching on the external anal sphincter. Dis Colon Rectum. 1996;39(11):12491254.

8. Tkalich O.V., Zharkov E.E., Ponomarenko A.A. et al. Efficacy of sphincter spasm elimination in chronic anal fissure using botulinum toxin type A and pneumodivultion. Annaly khirurgii. 2018; no. 23(5), pp. 314-321. (in Russ.).

9. Bagdasarjan L.S. Surgical treatment of anal fissure with pneumodivultion of the anal sphincter: dis. … kand. med. nauk, 2010: 115 p. (in Russ.).

10. Zharkov E.E. Complex treatment of chronic anal fissure: dis. … kand. med. nauk, 2009: 113 р. (in Russ.).

11. Yucel T, Gonullu D, Oncu M. et al. Comparison of controlledintermittent anal dilatation and lateral internal sphincterotomy in the treatment of chronic anal fissures: a prospective, randomized study. Int J Surg. 2009;7(3):228-231.