Clinical Outcome of 0.2% Glyceryl Trinitrate Topical Ointment Compared to Lateral Internal Sphincterotomy in the Treatment of Patient with Chronic Anal Fissure: A Randomized Control Trial.

The objective of study was to evaluate the clinical outcome of topical 0.2% Glyceryl trinitrate topical (GTN) ointment in the treatment of chronic anal fissure. This randomized control trial was carried out in the Colorectal Surgery Unit, Department of Surgery, Bangabandhu Sheikh Mujib Medical University (BSMMU), Bangladesh from May 2015 to April 2016. Total 94 patients were included in this trial, where 47(50.0%) patients were treated by 0.2% GTN ointment as Trial group 12 hourly for 8 weeks and 47(50.0%) patients by lateral internal sphincterotomy (LIS) as Control group in this study. Patients were randomized in two groups by lottery following purposive sampling. Post-procedural outcome variables with 6 months follow up were evaluated. Majority of the patients were found in between 20 to 40 years of age in both groups. The mean age was 34.6±10.4 years and 33.2±8.6 years in GTN and LIS respectively. Overall male female ratio was 0.88:1. All (100.0%) patients presented with pain in anus and 86.15% patients presented with per rectal bleeding. Pain relief in GTN arm versus LIS arm in 2nd and 6th week was 55.31% vs. 76.6%, 74.5% vs. 87.23% with no significant difference between two groups. But at 6 month it was 57.44% vs. 93.6% respectively. The fall in pain relief at 6th month in GTN arm was due to recurrence of fissure. At the end of 2nd, 6th week and 6month, cessation of bleeding improved gradually in both groups after treatment but the improvement was significantly better in LIS group than in GTN group indicating sphincterotomy stops bleeding better. Healing after 2nd week in both groups was minimum but equal 2(4.26%) patients. After 6 weeks LIS group had significant better healing than GTN 40(85.1%) versus 26(55.3%) with p value <0.001. In 6 month time GTN group had increased healing but LIS group had significant better healing than GTN group 42(89.36) vs. 32(68.08) with p value 0.004. Transient flatus and liquid incontinence were 8.51% and 6.4% respectively in LIS group with 0.0% in GTN group. Headache and recurrence were significantly higher in GTN group 61.7% and 34.04% with p<0.001. Lateral internal anal sphincterotomy is superior to the topical application of 0.2% nitroglycerin ointment in the treatment of chronic anal fissure with the advantages of good symptomatic relief, high rate of healing and a very low rate of transient continence disturbances.