Outcomes in Anorectal Malformations: Comparing Surgical Techniques for Perineal or Vestibular Fistula in a National Multicenter Study

What this Trial Is About

Researchers are evaluating mid- and long-term outcomes of various surgical methods used to correct anorectal malformations (ARM) with perineal or vestibular fistula. This national, multicenter study includes patients who had surgery between 2020 and 2027. The study compares techniques like posterior sagittal anorectoplasty (PSARP), anterior sagittal anorectoplasty (ASARP), and transanal proctoplasty (TAP) to understand their effects on fecal continence and other factors. The study involves groups of patients who underwent different surgical approaches: PSARP (including miniPSARP variants) and TAP. Data collected before the study start date will be analyzed retrospectively, while patients treated after that will be followed prospectively with yearly assessments until they achieve fecal continence or reach 6 years of age. The study measures postoperative complications, quality of life, constipation severity, bowel management needs, and time to achieve continence. Participants will be assessed annually with questionnaires and clinical evaluations until they reach fecal continence or turn 6 years old. Researchers will use the Krickenbeck score to evaluate fecal continence at 3 and 6 years post-surgery. Safety and complications will be monitored within 30 days after surgery, and quality of life will be assessed yearly. Total participation may last up to 6 years depending on continence achievement.

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