Comparing surgical methods for repairing perineal or vestibular fistula in children with anorectal malformations
Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study
This project will see if different surgical methods help children with perineal or vestibular fistula have better bowel control and fewer complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 0 Days to 18 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 21 sites (Florence, Florence and 20 other locations) |
| Trial ID | NCT07438691 on ClinicalTrials.gov |
What this trial studies
This ambispective multicenter cohort collects surgical and follow-up data on children with perineal or vestibular fistula repaired between 2020 and 2027, combining retrospective chart review with prospective annual visits. Functional outcomes including fecal continence (Krickenbeck score), postoperative complications (Clavien–Madadi classification), quality of life (HAQL), constipation and bowel management needs, and time to continence will be recorded. Patients enrolled after activation will be followed annually until continence is achieved or up to 6 years of age. Outcomes after PSARP (and variants), ASARP, and TAP will be compared to identify differences in mid- and long-term results.
Who should consider this trial
Good fit: Children under 18 with anorectal malformations presenting a perineal or vestibular fistula who underwent PSARP (or variants), ASARP, or TAP and whose parents or guardians provide consent are ideal candidates.
Not a fit: Patients with other types of anorectal malformations, those treated with different surgical techniques, or adults over 18 are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, this could help surgeons choose the best repair method to improve long-term fecal continence and quality of life for affected children.
How similar studies have performed: PSARP is established as the gold standard and some single-center comparisons exist, but there is limited multicenter long-term data directly comparing ASARP and TAP to PSARP, so this prospective multicenter approach adds needed evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Florence, Florence and 20 other locations
- Aou Meyer IRCSS — Florence, Florence, Italy (Recruiting)
- ASST Papa Giovanni XXIII — Bergamo, Italy (Not_yet_recruiting)
- Ospedale dei Bambini — Brescia, Italy (Not_yet_recruiting)
- UOC Chirurgia Pediatrica ARNAS Garibaldi, Catania — Catania, Italy (Not_yet_recruiting)
- Chirurgia pediatrica P.O. "V.Fazzi" — Lecce, Italy (Not_yet_recruiting)
- Policlinico di Modena — Modena, Italy (Not_yet_recruiting)
- Ospedale Maggiore della Carità di Novara — Novara, Italy (Not_yet_recruiting)
- Ospedale universitario di Padova — Padova, Italy (Not_yet_recruiting)
- Policlinico Universitario Paolo Giaccone di Palermo — Palermo, Italy (Not_yet_recruiting)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Not_yet_recruiting)
- PO: Santo Spirito — Pescara, Italy (Not_yet_recruiting)
- A.O.R. "S. Carlo" - Potenza — Potenza, Italy (Not_yet_recruiting)
- AUSL della Romagna - Ospedale Infermi Rimini — Rimini, Italy (Not_yet_recruiting)
- Azienda Ospedaliera S.Camillo-Forlanini — Roma, Italy (Not_yet_recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (Not_yet_recruiting)
- Ospedale Pediatrico Bambino Gesù — Roma, Italy (Not_yet_recruiting)
- Aou Senese — Siena, Italy (Not_yet_recruiting)
- Ospedale infantile Regina Margherita di Torino — Torino, Italy (Not_yet_recruiting)
- S. Antonio Abate - Trapani — Trapani, Italy (Not_yet_recruiting)
- Ospedale Filippo Del Ponte - Varese — Varese, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Universitaria Verona — Verona, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Riccardo Coletta — Meyer IRCSS
- Study coordinator: Riccardo Coletta
- Email: riccardo.coletta@meyer.it
- Phone: 390555662499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.