NON-INFERIORITY STUDY BETWEEN TOPICAL NIFEDIPINE 0.2% AND TOPICAL NIFEDIPINE 0.5% IN TREATMENT OF ANAL FISSURE | ||
ALEXMED ePosters | ||
Volume 7, Issue 3, July 2025, Pages 54-55 | ||
Document Type: Preliminary preprint short reports of original research | ||
DOI: 10.21608/alexpo.2025.421080.2262 | ||
Authors | ||
Khaled Abdelfattah Mohamed Madbouly1; walid Galal Abdelhakeem Elshazly2; Abdullah Mohammed Gamal-Eldin1; Ahmed AlaaEldin El Sayed Mohammed* 1 | ||
1Department of Surgery, Faculty of Medicine, Alexandria University. | ||
2Department of Surgery , faculty of medicine , university of Alexandria | ||
Abstract | ||
Chronic anal fissure is a common and painful anorectal condition characterized by a longitudinal tear in the anoderm, most frequently located at the posterior midline. Its pathophysiology is closely linked to internal anal sphincter hypertonia and reduced anodermal blood flow, which impair healing. Topical calcium channel blockers, such as nifedipine, have gained popularity due to their ability to reduce sphincter tone and promote fissure healing without the risks associated with surgical intervention. However, the optimal concentration of nifedipine for efficacy and tolerability remains unclear. AIM: This study aimed to determine whether 0.2% topical nifedipine is non-inferior to the standard 0.5% concentration in terms of fissure healing, pain relief, side effect profile, recurrence rate, continence, and quality of life in patients with chronic anal fissure. METHODS: A randomized, double-blind controlled trial was conducted at Alexandria Main University Hospital involving 142 adult patients with chronic anal fissure. Participants were randomly assigned to receive either 0.2% (Group A) or 0.5% (Group B) topical nifedipine ointment, applied twice daily for 4 weeks. Patients were followed for six months. Primary outcome was complete fissure healing by six weeks. Secondary outcomes included pain assessment using the Visual Analogue Scale (VAS), side effects, recurrence of symptoms, Wexner continence score, and quality of life using the SF-36 questionnaire. | ||
Keywords | ||
Anal fissure; Chronic; Calcium channel blockers; nifedipine | ||
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