NCT07438691

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Meyer Children's Hospital IRCCS · Academic / Other
• Sex: All
• Age: 0 Days – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anorectal Malformations

Timeline

• Start date: 2026-02-05
• Primary completion: 2033-02-01
• Completion: 2033-02-01
• First posted: 2026-02-27
• Last updated: 2026-03-27

Locations

21 sites across 1 country: Italy