The Efficacy of Botulinum Toxin Alone Versus Combined Botulinum Toxin and Topical Diltiazem in Chronic Anal Fissure

Istanbul Medipol University Hospital217 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

217

Conditions

Anal Fissure Chronic

Interventions

Botulinum Toxin Type A Injection [Botox]DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with complaints longer than 8 weeks (chronic anal fissure) * Patients who completed at least 24 months of follow-up (3rd day, 10th day, 1st-month, 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

Outcomes

Primary Outcomes

Fissure healing at 1 month

Evaluation of complete epithelization of the fissure by the principal investigator by rectal examination

Time frame: 1 month

Days to pain-free defecation

Patient reported time until pain-free defecation. This will be evaluated on 3rd day, 10th day and 1-month outpatient visits.

Time frame: 1 month

Secondary Outcomes

Complete healing at 48 months

Any recurrent symptoms evaluated by the surgeon within 2 months in the outpatient clinic and reported by the patient at phone call follow-up at 6 months, 12 months, 24 months, and 48 months.

Time frame: 48 months