Chronic anal fissure Digestive System
Conditions
Interventions
Participants are allocated in a 1:1 ratio using a pharmacy-generated blocked randomisation sequence with blocks of 10 (five allocations to each treatment within every block). The dispensing pharmacy p
Sponsors
Sheba Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged =18 years with clinically confirmed chronic anal fissure 2. Chronic anal fissure defined as a symptomatic fissure persisting for =6 weeks, with typical features on anorectal examination (e.g., sentinel tag, indurated edges, or exposed internal sphincter fibers) 3. Presence of fissure-related pain during or after defecation 4. Ability to provide informed consent 5. A threshold of 3 weeks was used to reflect institutional clinical practice and to include patients with persistent fissures refractory to conservative therapy
Exclusion criteria
Exclusion criteria: 1. Acute anal fissure (<3 weeks duration) 2. Anal fissure associated with inflammatory bowel disease (e.g., Crohn’s disease) 3. Previous anorectal surgery affecting the anal canal 4. Use of topical treatments for anal fissure within 2 weeks prior to enrollment 5. Known hypersensitivity to nifedipine, lidocaine, or components of the study ointment 6. Pregnancy or breastfeeding 7. Severe comorbid conditions that could interfere with study participation or outcome assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete fissure healing measured using data on clinical healing, defined as complete epithelialization of the fissure on anorectal examination, without associated pain during defecation at 6 weeks after treatment initiation;Pain reduction measured using a Visual Analog Scale (VAS) score at baseline and 6 weeks | — |
Countries
Israel
Contacts
Public ContactEdward Ram
Outcome results
None listed