RecruitingNCT07438691

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


Sponsor

Meyer Children's Hospital IRCCS

Enrollment

500 participants

Start Date

Feb 5, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 0 DaysMax Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

  • Age \>18 years
  • Other types of anorectal malformations
  • Surgical technique other than those specified

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Locations(21)

Aou Meyer IRCSS

Florence, 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

Policlinico Universitario Paolo Giaccone di Palermo

Palermo, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

PO: Santo Spirito

Pescara, Italy

A.O.R. "S. Carlo" - Potenza

Potenza, Italy

AUSL della Romagna - Ospedale Infermi Rimini

Rimini, Italy

Azienda Ospedaliera S.Camillo-Forlanini

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Aou Senese

Siena, Italy

Ospedale infantile Regina Margherita di Torino

Torino, Italy

S. Antonio Abate - Trapani

Trapani, Italy

Ospedale Filippo Del Ponte - Varese

Varese, Italy

Azienda Ospedaliera Universitaria Verona

Verona, Italy

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NCT07438691


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