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

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 design

Treatments tested in this trial

  • Not listed

Trial groups

500 Participants
are grouped into 2 trial groups