Effect of Additional Topical Diltiazem on Botulinum Toxin Injection for Chronic Anal Fissure: Retrospective Analysis of 217 Patients

E-10840098-772.02-786

Anal fissure (AF) is a painful tear extending from the anal canal to the dentate line. Although the exact pathophysiology is not known, an increase in anal tonus, decreased ano-dermal blood flow and local ischemia are possible mechanisms. The most effective treatment modality in chronic AF is lateral internal sphincterotomy however, incontinence rates are still reported as high as 8-30%. Topical diltiazem and botulinum toxin (BT) injection are good alternatives to surgery with lack of persistent side effects, easy applicability, and reproducibility, however, recurrence rates were reported up to 50% for each. A combination of BT with topical diltiazem may provide better results in terms of healing and recurrence. In this retrospective analysis a comparison of BT injection alone and BT injection combined with topical diltiazem treatment was performed.

2016-11-04

2020-06-30

2022-06-30

Completed

217

Inclusion Criteria: * Patients with complaints longer than 8 weeks (chronic anal fissure) * Patients who completed 24 months of follow-up (3rd day, 10th day, and 2nd-month face-to-face clinic visits and 6, 12, and 24 months phone calls) * Patients who received conservative treatments including topical diltiazem and nitrites Exclusion Criteria: * Patients with previous anal surgery (lateral internal sphincterotomy, hemorrhoidectomy, anal fistula) * Patients with inflammatory bowel diseases * Patients with accompanying anorectal disease (hemorrhoids, anal fistula, abscess) * Patients who underwent botulinum toxin injection within 1 year before recruitment * Patients with anterior, lateral, or multiple fissures * Comorbidities (AIDS, sexually transmitted disease, tuberculosis, leukemia) * Pregnancy * Prescription of calcium canal blockers or nitrites * Hypersensitivity to diltiazem or botulinum toxin * Patients without anal pain

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 217, 'type': 'ACTUAL'}}

2023-04-04