Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anorectal Malformations. Basic parameters: 0 Days — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Fecal Continence at 3 YEARS [Time frame: 3 years post-surgery]
- Fecal Continence at 6 Years [Time frame: 6 years post-surgery]
Secondary outcome measures (5)
- Postoperative Complications Within 30 Days [Time frame: Within 30 days after surgical correction]
- ectal Mucosal Prolapse [Time frame: From surgery until 6 years of age or achievement of fecal continence (up to 6 years)]
- Quality of Life (HAQL Questionnaire) [Time frame: Assessed annually until 6 years of age or achievement of fecal continence]
- Constipation Severity and Bowel Management Requirements [Time frame: Assessed annually until 6 years of age or achievement of fecal continence]
- time to Achievement of Fecal Continence [Time frame: From date of surgery until continence is achieved or up to 6 years of age]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Age >18 years
- Other types of anorectal malformations
- Surgical technique other than those specified
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 21 centers
- Aou Meyer IRCSS — Florence
- ASST Papa Giovanni XXIII — Bergamo
- Ospedale dei Bambini — Brescia
- UOC Chirurgia Pediatrica ARNAS Garibaldi, Catania — Catania
- Chirurgia pediatrica P.O. "V.Fazzi" — Lecce
- Policlinico di Modena — Modena
- Ospedale Maggiore della Carità di Novara — Novara
- Ospedale universitario di Padova — Padova
- … and 13 more centers
Identifiers
NCT: NCT07438691 · MAR-ITA