Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorMeyer Children's Hospital IRCCS

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 2 trial groups
Group A: PSARP group
Group B: TAP group

Trial outcomes

Primary outcomes

1

Fecal Continence at 3 YEARS

Measured by proportion of children achieving fecal continence according to Krickenbeck score.

Time frame
3 years post-surgery
2

Fecal Continence at 6 Years

Measured by proportion of children achieving fecal continence according to Krickenbeck score.

Time frame
6 years post-surgery

Secondary outcomes

1

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
2

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)
3

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
4

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

Other outcomes

Sponsors and contacts

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