Long-Term Results of Medical and Surgical Methods for Elimination of the Internal Anal Sphincter Spasm in Chronic Anal Fissure (NCT03855046)

Aim: evaluation of long-term results of injection of botulinum toxin type A into the internal anal sphincter and performing lateral internal sphincterotomy in combination with excision of chronic anal fissure.

Materials and methods. The study included 176 patients (73 (41.5 %) men and 103 (58.5 %) women) older than 18 years; randomization into the compared groups was carried out by random number generation in a computer program. Patients, researchers and surgeons were not blinded. Patients of the main group underwent fissure excision in combination with relaxation of the internal anal sphincter by botulinum toxin type A (BTA) at a dosage of 40 units, patients of the control group underwent lateral internal sphincterotomy (LIS) with excision of chronic anal fissure. Long-term results of complex treatment were studied in 126 patients (54 (43 %) men and 72 (57 %) women), the median follow-up was 12.3 (12.2; 15.7) months. Statistical analysis was carried out in the program Statistica 13.3 (TIBCO Software Inc., USA).

Results. In the long-term postoperative period, the indicators of mean resting anal pressure were lower in the LIS group (p = 0.04). The compared groups were comparable in terms of the level mean squeeze anal pressure (p = 0.69); however, in patients of the BTA group, the level of this indicator increased over time (p = 0.001). None of the patients of the compared groups had anal incontinence and relapse of the disease.

Discussion. In the framework of the performed study, in some patients from the compared groups, spasm of the internal anal sphincter persisted throughout the observation period, and in some patients it occurred again, while no signs of relapse fissure were detected. The functional and clinical results of treatment obtained by us cast doubt on the exclusivity of the increased tone of the internal anal sphincter as the main link in the pathogenesis of chronic anal fissure in some patients and indicates the presence of other factors in combination with which the course of the disease is determined. The above facts do not exclude the possibility of recurrence of anal fissure in a more distant period of observation.

Conclusion. Medical relaxation with botulinum toxin type A at a dosage of 40 units can serve as an alternative to lateral internal sphincterotomy as a method of eliminating spasm of the internal anal sphincter

1. Agapov M.A., Aliev F.Sh., Achkasov S.I., Bashankaev B.N., Biryukov O.M., Blagodarnyj L.A., et al. Anal fissure. Koloproktologia. 2021;20(4):10–21. (In Russ.). DOI: 10.33878/2073-7556-2021-20-4-10-21

2. Mapel D.W., Schum M., Von Worley A. The epidemiology and treatment of anal fissures in a population-based cohort. BMC Gastroenterol. 2014;14:129. DOI: 10.1186/1471-230X-14-129

3. Blagodarnyj L.A., Poletov N.N., Zharkov E.E. Pathogenesis of anal fissures. Koloproktologia. 2007;1(19):38–41. (In Russ.).

4. Shelygin Yu.A., Frolov S.A., Orlova L.P., Podmarenkova L.F., Poletov N.N., Zharkov E.E., et al. Anal incontinence in patients who have undergone excision of the anal fissure in combination with lateral subcutaneous sphincterotomy. Koloproktologia. 2008;3(25):18–24. (In Russ.).

5. Stewart D.B. Sr, Gaertner W., Glasgow S., Migaly J., Feingold D., Steele S.R. Clinical practice guideline for the management of anal fissures. Disease Colon Rectum. 2017;60(1):7–14. DOI: 10.1097/DCR.0000000000000735

6. Notaras M.J. Lateral subcutaneous sphincterotomy for anal fissure — a new technique. Proc R Soc Med. 1969;62(7):713.

7. Ram E., Alper D., Stein G.Y., Bramnik Z., Dreznik Z. Internal anal sphincter function following lateral internal sphincterotomy for anal fissure: A long-term manometric study. Ann Surg. 2005;242(2):208–11. DOI: 10.1097/01.sla.0000171036.39886.fa

8. Khryukin R.Yu., Kostarev I.V., Arslanbekova K.I., Nagudov M.A., Zharkov E.E. Botulinum toxin type A and lateral subcutaneous sphincterotomy for chronic anal fissure with the sphincter. What to choose? (systematic literature review and meta-analysis). Koloproktologia. 2020;19(2):113–28. (In Russ.). DOI: 10.33878/2073-7556-2020-19-2-113-128

9. Khryukin R.Y., Zharkov E.E., Goloktionov N.A., Nekhrikova S.V., Medvedev V.Y., Slozhenikin S.V., et al. Treatment of chronic anal fissure botulinum toxin type A 40 U in comparison with lateral subcutaneous sphincterotomy (NCT03855046). Koloproktologia. 2022;21(1):60–70. (In Russ.). DOI: 10.33878/2073-7556-2022-21-1-60-70

10. Goloktionov N.A., Kashnikov V.N., Tkalich O.V., Ponomarenko A.A., Khryukin R.Y., Kostarev I.V., et al. Comparison of different doses botulinum toxin type A efficacy in chronic anal fissure treatment. Ser J Exp Clin Res. 2022;23(1):13–28. DOI: 10.2478/sjecr-2022-0006

11. Jorge J.M., Wexner S.D. Etiology and management of fecal incontinence. Disease Colon Rectum. 1993;36(1):77–97. DOI: 10.1007/BF02050307

12. Shelygin Yu.A., Fomenko O.Yu., Veselov V.V., Belousova S.V., Aleshin D.V., Vyaz'min D.O. Normative indicators of pressure in the anal canal with non-perfusion manometry. Koloproktologia. 2015;3(53):4–9. (In Russ.).

13. Ebinger S.M., Hardt J., Warschkow R., Schmied B.M., Herold A., Post S., et al. Operative and medical treatment of chronic anal fissures — a review and network meta-analysis of randomized controlled trials. J Gastroenterol. 2017;52(6):663–76. DOI: 10.1007/s00535-017-1335-0

14. Nelson R.L., Thomas K., Morgan J., Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012;2012(2):CD003431. DOI: 10.1002/14651858.CD003431.pub3

15. Nelson R.L., Chattopadhyay A., Brooks W., Platt I., Paavana T., Earl S. Operative procedures for fissure in ano. Cochrane Database Syst Rev. 2011;2011(11):CD002199. DOI: 10.1002/14651858.CD002199.pub4

16. Nelson R. A systematic review of medical therapy for anal fissure. Dis Colon Rectum. 2004;47(4):422–31. DOI: 10.1007/ s10350-003-0079-5

17. Shelygin Y.A., Tkalich O.V., Ponomarenko A.A., Fomenko O.Y., Khryukin R.Y., Zharkov E.E., et al. Follow up results of combination treatment of chronic anal fissure. International Journal of Pharmaceutical Research. 2020;12(2):244‒9. DOI: 10.31838/ijpr/2020.SP2.040 18. Xynos E., Tzortzinis A., Chrysos E., Tzovaras G., Vassilakis J.S. Anal manometry in patients with fissure-in-ano before and after internal sphincterotomy. Int J Colorectal Dis. 1993;8(3):125–8. DOI: 10.1007/BF00341183

18. van Meegdenburg M.M., Trzpis M., Heineman E., Broens P.M. Increased anal basal pressure in chronic anal fissures may be caused by overreaction of the anal-external sphincter continence reflex. Med Hypotheses. 2016;94:25–9. DOI: 10.1016/j.mehy.2016.06.005

19. Shaoming C., Qinghuan Y. A new theory on the cause of anal fissure impaction. Journal of Coloproctology (Rio de Janeiro). 2020;40(4):321‒5. DOI: 10.1016/j.jcol.2020.06.006