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

Recruitingn/aAges 0 Days - 18 YearsAllMeyer Children's Hospital IRCCS
NCT07438691 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pediatric patients (\<18 years) * Diagnosis of anorectal malformation with perineal or vestibular fistula * Surgical correction with PSARP (or variants), ASARP, or TAP * Signed informed consent from parents/legal guardians Exclusion Criteria: * Age \>18 years * Other types of anorectal malformations * Surgical technique other than those specified
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What it tests

  • Not listed
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Where

21 sites
Aou Meyer IRCSS
Florence, Italy
ASST Papa Giovanni XXIII
Bergamo, Italy
Ospedale dei Bambini
Brescia, Italy
UOC Chirurgia Pediatrica ARNAS Garibaldi, Catania
Catania, Italy
Chirurgia pediatrica P.O. "V.Fazzi"
Lecce, Italy
Policlinico di Modena
Modena, Italy
Ospedale Maggiore della Carità di Novara
Novara, Italy
Ospedale universitario di Padova
Padova, Italy

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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