Effect of Additional Topical Diltiazem on Botulinum Toxin Injection for Chronic Anal Fissure

Study Overview
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Brief Summary
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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.

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

Conditions
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Anal Fissure Chronic

Intervention / Treatment
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* Drug: Botulinum Toxin Type A Injection [Botox]
* Drug: Botulinum Toxin Type A Injection [Botox] + Diltiazem Hydrochloride 20 Mg/G Rectal Gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Botulinum toxin group<br>The procedures were performed at outpatient clinic without anesthesia. Lyophilized 100 IU BT Type-A (BOTOX, Alergan, CA, USA) was applied after diluted with 1 cc saline. A 26-G injector was used to inject 25 unit toxin in every 4 quadrants, to the alignment of clock 12, 3, 6, and 9 to internal anal sphincters. | Drug: Botulinum Toxin Type A Injection [Botox]<br> <br> |
| Botulinum toxin plus topical diltiazem group<br>The procedures were performed at outpatient clinic without anesthesia. Lyophilized 100 IU BT Type-A (BOTOX, Alergan, CA, USA) was applied after diluted with 1 cc saline. A 26-G injector was used to inject 25 unit toxin in every 4 quadrants, to the alignment of clock 12, 3, 6, and 9 to internal anal sphincters. After BT injection, topical 2% diltiazem gel was prescribed, applied 2 times per day for 10 days (2 doses of 1 gr each per day) | Drug: Botulinum Toxin Type A Injection [Botox] + Diltiazem Hydrochloride 20 Mg/G Rectal Gel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fissure healing at 1 month | Evaluation of complete epithelization of the fissure by the principal investigator by rectal examination | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence at 24 months | Any recurrent symptoms reported by the patient at phone call follow-up | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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botulinum toxin, anal fissure, diltiazem