NCT05797220

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

Retrospective Analysis on the Efficacy of Botulinum Toxin Alone Versus Combined Botulinum Toxin and Topical Diltiazem in Chronic Anal Fissure: Short and Long-term Outcomes From a Single Center

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 217 (actual)
• Sponsor: Istanbul Medipol University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Anal Fissure Chronic

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A Injection [Botox]
DRUG	Botulinum Toxin Type A Injection [Botox] + Diltiazem Hydrochloride 20 Mg/G Rectal Gel

Timeline

• Start date: 2016-11-04
• Primary completion: 2020-06-30
• Completion: 2024-08-30
• First posted: 2023-04-04
• Last updated: 2024-09-04

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study