Actively Recruiting

Age: 0Days - 18Years
All Genders
NCT07438691

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

Led by Meyer Children's Hospital IRCCS · Updated on 2026-03-27

500

Participants Needed

21

Research Sites

364 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Days - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients younger than 18 years
  • Diagnosis of anorectal malformation with perineal or vestibular fistula
  • Surgical correction performed with PSARP (or variants), ASARP, or TAP techniques
  • Signed informed consent from parents or legal guardians
Not Eligible

You will not qualify if you...

  • Age older than 18 years
  • Presence of other types of anorectal malformations
  • Surgical correction using techniques other than PSARP, ASARP, or TAP

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 21 locations

1

Aou Meyer IRCSS

Florence, Florence, Italy, 50139

Actively Recruiting

2

ASST Papa Giovanni XXIII

Bergamo, Italy

Not Yet Recruiting

3

Ospedale dei Bambini

Brescia, Italy

Not Yet Recruiting

4

UOC Chirurgia Pediatrica ARNAS Garibaldi, Catania

Catania, Italy

Not Yet Recruiting

5

Chirurgia pediatrica P.O. "V.Fazzi"

Lecce, Italy

Not Yet Recruiting

6

Policlinico di Modena

Modena, Italy

Not Yet Recruiting

7

Ospedale Maggiore della Carità di Novara

Novara, Italy

Not Yet Recruiting

8

Ospedale universitario di Padova

Padova, Italy

Not Yet Recruiting

9

Policlinico Universitario Paolo Giaccone di Palermo

Palermo, Italy

Not Yet Recruiting

10

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Not Yet Recruiting

11

PO: Santo Spirito

Pescara, Italy

Not Yet Recruiting

12

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

Potenza, Italy

Not Yet Recruiting

13

AUSL della Romagna - Ospedale Infermi Rimini

Rimini, Italy

Not Yet Recruiting

14

Azienda Ospedaliera S.Camillo-Forlanini

Roma, Italy

Not Yet Recruiting

15

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Not Yet Recruiting

16

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Not Yet Recruiting

17

Aou Senese

Siena, Italy

Not Yet Recruiting

18

Ospedale infantile Regina Margherita di Torino

Torino, Italy

Not Yet Recruiting

19

S. Antonio Abate - Trapani

Trapani, Italy

Not Yet Recruiting

20

Ospedale Filippo Del Ponte - Varese

Varese, Italy

Not Yet Recruiting

21

Azienda Ospedaliera Universitaria Verona

Verona, Italy

Not Yet Recruiting

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Research Team

R

Riccardo Coletta

CONTACT

L

Lucia Paolini

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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