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COMPLETED
NCT07543315
PHASE3

Low Versus High Dose OnabotulinumtoxinA for Chronic Anal Fissure

Sponsor: Tanta University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the efficacy of botulinum toxin injection in treatment of patients with chronic anal fissures comparing between two doses of botulinum toxin injection focusing on healing rate, fissure pain, incontinence and return to daily activity. patients will be divided into two groups group A) will receive 50IU from Botulinium toxin type A in the form of two injections at 3 o'clock and 9 o'clock without any anasthesia. While group B) will receive low dose injection in the form of 20IU by the same technique.

Official title: Low Versus High Dose OnabotulinumtoxinA for Chronic Anal Fissure: A Randomized Clinical Trial With 1-Year Follow-up

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-08-01

Completion Date

2026-08-30

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

DRUG

injection of Botulinum type A

injection of low dose 20 IU of Botoulinum toxin type A to arm 1 and high dose 50 IU to arm 2

Locations (1)

Faculty of Medicine Tanta University

Tanta, Egypt