An observational study in Anorectal Malformations, sponsored by Meyer Children's Hospital IRCCS. Recruiting at 21 sites in Italy. Open to participants aged 0 Days to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Meyer Children's Hospital IRCCS · Observational
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.
This is a national, multicenter ambispective (retro-prospective) longitudinal cohort study. The study includes patients who underwent surgical correction between 2020 and 2027.
Data collected prior to study activation (2020-study start date) will be analyzed retrospectively from medical records, while patients enrolled after study activation will be followed prospectively with annual assessments until achievement of fecal continence or up to 6 years of age, whichever occurs first.
Anorectal malformations (ARM) are rare congenital anomalies requiring complex reconstructive surgery. Posterior sagittal anorectoplasty (PSARP) remains the gold standard; however, alternative techniques such as anterior sagittal anorectoplasty (ASARP) and transanal proctoplasty (TAP) are increasingly adopted.
This study aims to compare surgical techniques in terms of:
Fecal continence (Krickenbeck score)
Postoperative complications (Clavien-Madadi classification)
Quality of life (HAQL questionnaire)
Constipation and bowel management requirements
Time to continence achievement
Patients will be followed annually until 6 years of age or until continence is reached, whichever occurs first.
30 studies on the registry are indexed under Anorectal Malformations; 10 are open to participants now.
This study's planned enrollment of 500 is above the median of 190 across 18 observational studies indexed under Anorectal Malformations.
Browse Anorectal Malformations studies →Meyer Children's Hospital IRCCS is the lead sponsor of 78 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pediatric patients (\<18 years) diagnosed with anorectal malformation with perineal or vestibular fistula undergoing surgical correction between 2020 and 2027.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing posterior sagittal anorectoplasty (PSARP) or its variants (miniPSARP)
Patients undergoing transanal proctoplasty (TAP).
Fecal Continence at 3 YEARS
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
Time frame: 3 years post-surgery
Fecal Continence at 6 Years
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
Time frame: 6 years post-surgery
Postoperative Complications Within 30 Days
Presence and severity of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Madadi pediatric surgical complication grading system.
Time frame: Within 30 days after surgical correction
ectal Mucosal Prolapse
Occurrence of rectal mucosal prolapse during follow-up, including frequency and need for medical or surgical treatment.
Time frame: From surgery until 6 years of age or achievement of fecal continence (up to 6 years)
Quality of Life (HAQL Questionnaire)
The HAQL questionnaire evaluates disease-specific quality of life in patients with Hirschsprung's disease and anorectal malformations. The questionnaire generates domain-specific scores and a total score ranging from 0 to 100, where higher scores indicate better quality of life. Validated Italian age-specific versions of the HAQL questionnaire will be used when applicable.
Time frame: Assessed annually until 6 years of age or achievement of fecal continence
Constipation Severity and Bowel Management Requirements
Presence and severity of constipation, including need for dietary measures, laxatives, enemas, or structured bowel management programs, evaluated according to the Krickenbeck criteria.
Time frame: Assessed annually until 6 years of age or achievement of fecal continence
time to Achievement of Fecal Continence
Time from surgical correction to achievement of fecal continence, defined according to the Krickenbeck score (voluntary bowel movements, ability to verbalize urge, and absence of significant soiling).
Time frame: From date of surgery until continence is achieved or up to 6 years of age
Started Feb 2026 (actual). Primary completion is estimated for Feb 2033, 84 months after the start.
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Meyer Children's Hospital IRCCS