Comparing surgical methods for repairing perineal or vestibular fistula in children with anorectal malformations
Official title: Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study
Run by Meyer Children's Hospital IRCCS · NCT07438691 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 0 Days to 18 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 21 sites (Florence, Florence and 20 other locations) |
| Status | Recruiting |
| Started | February 5, 2026 |
| Main results expected | February 2033 |
| Study ends | February 2033 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07438691 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 15 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Validating the Baylor Continence Scale for Turkish children with anorectal malformations
The Baylor Continence Scale will be tested in Turkish-speaking children aged 6–18 who had surgery for anorectal malformations to see if it measures bowel control reliably.
-
Long-term outcomes for children with Hirschsprung's disease and anorectal malformations
This study looks at how well children with Hirschsprung's disease and anorectal malformations are doing in the long run after their surgeries to help families understand their health and quality of life better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.