Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study
MAR-ITA
1 other identifier
observational
500
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2026
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2026
CompletedFirst Submitted
Initial submission to the registry
February 23, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2033
March 27, 2026
March 1, 2026
7 years
February 23, 2026
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fecal Continence at 3 YEARS
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
3 years post-surgery
Fecal Continence at 6 Years
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
6 years post-surgery
Secondary Outcomes (5)
Postoperative Complications Within 30 Days
Within 30 days after surgical correction
ectal Mucosal Prolapse
From surgery until 6 years of age or achievement of fecal continence (up to 6 years)
Quality of Life (HAQL Questionnaire)
Assessed annually until 6 years of age or achievement of fecal continence
Constipation Severity and Bowel Management Requirements
Assessed annually until 6 years of age or achievement of fecal continence
time to Achievement of Fecal Continence
From date of surgery until continence is achieved or up to 6 years of age
Study Arms (2)
PSARP group
Patients undergoing posterior sagittal anorectoplasty (PSARP) or its variants (miniPSARP)
TAP group
Patients undergoing transanal proctoplasty (TAP).
Eligibility Criteria
Pediatric patients (\<18 years) diagnosed with anorectal malformation with perineal or vestibular fistula undergoing surgical correction between 2020 and 2027.
You may qualify if:
- 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
You may not qualify if:
- Age \>18 years
- Other types of anorectal malformations
- Surgical technique other than those specified
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Aou Meyer IRCSS
Florence, Florence, 50139, Italy
ASST Papa Giovanni XXIII
Bergamo, Italy
Ospedale dei Bambini
Brescia, Italy
UOC Chirurgia Pediatrica ARNAS Garibaldi, Catania
Catania, Italy
Chirurgia pediatrica P.O. "V.Fazzi"
Lecce, Italy
Policlinico di Modena
Modena, Italy
Ospedale Maggiore della Carità di Novara
Novara, Italy
Ospedale universitario di Padova
Padua, Italy
Policlinico Universitario Paolo Giaccone di Palermo
Palermo, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
PO: Santo Spirito
Pescara, Italy
A.O.R. "S. Carlo" - Potenza
Potenza, Italy
AUSL della Romagna - Ospedale Infermi Rimini
Rimini, Italy
Azienda Ospedaliera S.Camillo-Forlanini
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Ospedale Pediatrico Bambino Gesù
Roma, Italy
Aou Senese
Siena, Italy
Ospedale infantile Regina Margherita di Torino
Torino, Italy
S. Antonio Abate - Trapani
Trapani, Italy
Ospedale Filippo Del Ponte - Varese
Varese, Italy
Azienda Ospedaliera Universitaria Verona
Verona, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Riccardo Coletta
Meyer IRCSS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MEDICAL DOCTOR
Study Record Dates
First Submitted
February 23, 2026
First Posted
February 27, 2026
Study Start
February 5, 2026
Primary Completion (Estimated)
February 1, 2033
Study Completion (Estimated)
February 1, 2033
Last Updated
March 27, 2026
Record last verified: 2026-03