Single centre randomized comparative trial of lateral internal sphincterotomy versus 2% diltiazem in chronic anal fissure
Keywords:Anal fissure, Diltiazem, Sphincterotomy
Background: Anal fissures are often encountered in surgical practice with surgery the gold standard management for chronic anal fissures. Recently the widespread use of pharmacologic agents for chronic fissures has increased. In our study we compare topical 2% diltiazem with lateral sphincterotomy with respect to symptoms such as relief of pain, ulcer healing, and side effects of treatments.
Methods: A prospective comparative study, a total of 80 patients were randomized into 2 groups 40 each. Group A patients were subjected to open internal lateral sphincterotomy and group B to 2% topical diltiazem. The patients in both groups were followed up at 1st, 4th, 14th weeks and 6 months in OPD and were assessed for pain, sphincter tone and complications.
Results: In group A (lateral anal sphincterotomy), patients achieved a good pain relief with a mean pain score of 1.98 by one week post procedure whereas group B (2% diltiazem) had taken 14 weeks to achieve similar pain relief (pain score of 1.5). At the end of 6 months, healing of fissure was noted in 100% of group A and in 90% of group B. 4 patients (10%) had recurrences in group B. Flatus incontinence was reported in 2 patients (5%) in group A although transient.
Conclusions: Lateral anal sphincterotomy is superior to 2% diltiazem especially in healing of fissure, pain relief, quality of life and recurrence. Pharmacologic agents should be reserved for patients who are unfit or unwilling for surgery or can be used as a bridge therapy till sphincterotomy can be planned.
Leong APK. The pharmacological treatment of anal fissures- a future role in the primary care. Singapore Med J. 2003;44:136-7.
Jensen SL. Diet and other risk factors for fissure-in-ano. A prospective case control study. Dis Colon Rectum. 1988;31:770-3.
Perry WB, Dykes SL, Buie WD, Rafferty JF. Standards practice task force of the American Society of Colon and Rectal Surgeons Practice parameters for the management of anal fissures (3rd. Revision). Dis Colon Rectum 2010;53:1110-5.
Schouten WR, Briel JW, Auwerda JJ, De Graaf EJ. Ischemic nature of anal fissure. Br J Surg. 1996;83:63-5.
Tocchi A, Mazzoni G, Miccini M, Cassini D, Bettelli E, Brozzetti S. Total lateral sphincterotomy for anal fissure. Int J Colorect Dis. 2004;19(3):245-9.
Marion J, Scholefield JH. Anal fissure and chemical sphincterotomy. In: Taylor I, Johnson CD, eds. Recent advances in Surgery. 24th Edn. Churchill Livingstone; 2001: 115.
Griffin N, Acheson AG, Tung P, Sheard C, Glazebrook C, Scholefield JH. Quality of life in patients with chronic anal fissure colorectal disease. 2004;6(1):39-44.
Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane database Syst Rev. 2012(2).
Jennifer K. Lowney, James W. Fleshman, Jr., Benign disorders of the ano rectum, Michael J. Zinner MJ, Ashley SW, eds. Maingot's Abdominal Operations. 11th edn. Tata McGraw Hill; 2007: 680-684.
Mazier WP. An evaluation of the surgical treatment of anal fissure. Dis Colon Rectum. 1975;47:33-9.
Wiley M, Day P, Rieger N. Open vs. closed lateral internal sphincterotomy for indio-pathic fissure-inano. A prospective, randomized, controlled trial. Dis Colon Rectum. 2004;47:847-52.
Sritharan H, Kumar NKA, Ibrahim MIS. Management of chronic anal fissures: a narrative review. Int Surg J. 2020;7:1327-31.
Shrivastava UK, Jain BK, Kumar P. A comparison of the effects of diltiazem and glyceryl trinitrate ointment in the treatment of chronic anal fissure: a randomized clinical trial. Surg Today. 2007;37:482- 5.
Ala S, Saeedi M, Hadianamrei B. Topical diltiazem vs. topical glyceryl trinitrate in the treatment of chronic anal fissure: a prospective, randomized, double-blind trial. Acta Gastroenterol Belg. 2012;75:438-42
Carapeti E, Kamm M, Evans B, Phillips R. Topical Diltiazem and Bethanechol decrease anal sphincter pressure and heal anal fissures without side effects. Dis Colon Rectum. 1999;43(10):1359-62.
Vaithianathan R, Panneerselvam S. Randomised prospective controlled trial of topical 2% diltiazem versus lateral internal sphincterotomy for the treatment of chronic fissure in ano. Indian J Surg. 2015;77(3):1484-7.
Giridhar CM, Babu P, Rao KS. A comparative study of lateral sphincterotomy and 2% diltiazem gel local application in the treatment of chronic fissure in ano. J Clin Diagn Res. 2014;8:1-2.
Popat A, Pandey CP, Agarwal K, Srivastava VP, Sharma SM, Dixit A. A comparative study of role of topical diltiazem 2% organo gel and lateral internal sphincterotomy for the management of chronic fissure in ano. Int J Contemp Med Res. 2016;3(5):1363-5.