Clinical Trial

Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study

Study acronym: MAR-ITA
Recruiting
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Summary
This is a national, multicenter, retro-prospective longitudinal cohort study evaluating mid- and long-term outcomes of different surgical techniques used for the correction of anorectal malformations (ARM) with perineal or vestibular fistula. Patients undergoing surgical correction between 2020 and 2027 will be included. Functional outcomes, particularly fecal continence assessed using the Krickenbeck score, will be evaluated at 3 and 6 years post-surgery or until continence is achieved.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-02-23; most recent amendment 2026-03-23.
Trial Details
NCT Number NCT07438691
Lead Sponsor Meyer Children's Hospital IRCCS
Conditions Anorectal Malformations
Enrollment 500 participants
Start Date 2026-02-05
Primary Completion 2033-02 (estimated)
Study Completion 2033-02 (estimated)
Updated on ClinicalTrials.gov 2026-03-27