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Which surgery works best for rare birth defect? major study aims to find out

NCT ID NCT07438691

Knowledge-focused Sponsor: Meyer Children's Hospital IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at 500 children with a rare birth defect affecting the anus and rectum. Researchers will compare different surgical techniques to see which one leads to better bowel control and fewer complications. The children will be followed for up to 6 years after surgery. The goal is to help doctors choose the best approach for each child.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help surgeons choose the best technique to improve long-term bowel control in children with anorectal malformations.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test a new drug or cure, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pediatric patients (\<18 years) diagnosed with anorectal malformation with perineal or vestibular fistula undergoing surgical correction between 2020 and 2027.

Ages

0 days to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Anorectal Malformations imperforate anus low anorectal malformation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anorectal malformations

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.R. "S. Carlo" - Potenza

    NOT_YET_RECRUITING

    Potenza, Italy

  • ASST Papa Giovanni XXIII

    NOT_YET_RECRUITING

    Bergamo, Italy

  • AUSL della Romagna - Ospedale Infermi Rimini

    NOT_YET_RECRUITING

    Rimini, Italy

  • Aou Meyer IRCSS

    RECRUITING

    Florence, Florence, 50139, Italy

  • Aou Senese

    NOT_YET_RECRUITING

    Siena, Italy

  • Azienda Ospedaliera S.Camillo-Forlanini

    NOT_YET_RECRUITING

    Roma, Italy

  • Azienda Ospedaliera Universitaria Verona

    NOT_YET_RECRUITING

    Verona, Italy

  • Chirurgia pediatrica P.O. "V.Fazzi"

    NOT_YET_RECRUITING

    Lecce, Italy

  • Fondazione IRCCS Policlinico San Matteo

    NOT_YET_RECRUITING

    Pavia, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    NOT_YET_RECRUITING

    Roma, Italy

  • Ospedale Filippo Del Ponte - Varese

    NOT_YET_RECRUITING

    Varese, Italy

  • Ospedale Maggiore della Carità di Novara

    NOT_YET_RECRUITING

    Novara, Italy

  • Ospedale Pediatrico Bambino Gesù

    NOT_YET_RECRUITING

    Roma, Italy

  • Ospedale dei Bambini

    NOT_YET_RECRUITING

    Brescia, Italy

  • Ospedale infantile Regina Margherita di Torino

    NOT_YET_RECRUITING

    Torino, Italy

  • Ospedale universitario di Padova

    NOT_YET_RECRUITING

    Padova, Italy

  • PO: Santo Spirito

    NOT_YET_RECRUITING

    Pescara, Italy

  • Policlinico Universitario Paolo Giaccone di Palermo

    NOT_YET_RECRUITING

    Palermo, Italy

  • Policlinico di Modena

    NOT_YET_RECRUITING

    Modena, Italy

  • S. Antonio Abate - Trapani

    NOT_YET_RECRUITING

    Trapani, Italy

  • UOC Chirurgia Pediatrica ARNAS Garibaldi, Catania

    NOT_YET_RECRUITING

    Catania, Italy

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