Abstract
Objective: To evaluate the efficacy of topical diltiazem and lateral internal sphincterotomy in the treatment of chronic anal fissure with emphasis on pain relief and complete healing of the fissure.
Study Design: A Randomized controlled trial.
Duration of study: One year after approval of the synopsis, General Surgery Unit 1 of SPH / Postgraduate Medical Institute Quetta
Methodology: Randomized controlled trial designed and implemented at General Surgery Unit-I, Sandeman Provincial Hospital/Postgraduate Medical Institute, Quetta, over a span of one year after synopsis approval. The total number of patients with chronic anal fissure was 92, ranging from 15 to 65 years, who were recruited by consecutive non-probability sampling. Patients were randomly allocated in equal numbers to two groups. Group A received topical diltiazem cream twice daily for 6 weeks, and Group B had lateral internal sphincterotomy performed under local anesthetic. Patients underwent follow-up examinations at the first, second, and third visits for pain relief and fissure healing. We analyzed the data using SPSS 27. We used p≤0.05 as the threshold for statistical significance and performed the chi-square test.
Results: We included 92 patients, with 46 in each group. The mean age was 39.52±14.55 years in the diltiazem group and 41.01±11.45 years in the LIS group, with no significant difference between groups (p=0.58). The mean fissure duration was 8.0±1.5 weeks and 8.5±1.9 weeks in the diltiazem and LIS groups, respectively (p=0.164). Male patients comprised 57% and 55% of the respective groups (p=0.833). At the first visit, 87% of patients in both groups reported pain. At the second visit, pain persisted in 78% of the diltiazem group compared with 54.34% of the LIS group. By the third visit, pain was present in 23.9% of diltiazem-treated patients compared with none in the LIS group, demonstrating a significant difference (p=0.006). Regarding complete healing, 9 patients (19.5%) in the diltiazem group had healed by the second visit and 16 (34.7%) by the third visit. In contrast, 21 patients (45.6%) in the LIS group healed at the first visit, 37 (80.4%) at the second, and 44 (95.6%) at the third visit. The difference in healing was statistically significant (p=0.03).
Conclusion: Lateral internal sphincterotomy was shown to be superior to topical diltiazem in terms of its ability to provide rapid pain relief and to achieve a significantly greater percentage of complete healing of the fissures in chronic anal fissure. Topical diltiazem is, however, a good non-surgical and safe therapeutic alternative, especially in patients who are not candidates for or unwilling to have surgery. It could therefore be considered a conservative first-line treatment in selected patients, whereas LIS is more effective when quick healing is needed.