About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age >18 years
Other types of anorectal malformations
Surgical technique other than those specified
Trial population
Pediatric patients (\<18 years) diagnosed with anorectal malformation with perineal or vestibular fistula undergoing surgical correction between 2020 and 2027.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Fecal Continence at 3 YEARS
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
Fecal Continence at 6 Years
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
Secondary outcomes
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.
ectal Mucosal Prolapse
Occurrence of rectal mucosal prolapse during follow-up, including frequency and need for medical or surgical treatment.
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.
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.
Sponsors and contacts
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