Actively Recruiting
Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study
Led by Meyer Children's Hospital IRCCS · Updated on 2026-03-27
500
Participants Needed
21
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients younger than 18 years
- Diagnosis of anorectal malformation with perineal or vestibular fistula
- Surgical correction performed with PSARP (or variants), ASARP, or TAP techniques
- Signed informed consent from parents or legal guardians
You will not qualify if you...
- Age older than 18 years
- Presence of other types of anorectal malformations
- Surgical correction using techniques other than PSARP, ASARP, or TAP
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Aou Meyer IRCSS
Florence, Florence, Italy, 50139
Actively Recruiting
2
ASST Papa Giovanni XXIII
Bergamo, Italy
Not Yet Recruiting
3
Ospedale dei Bambini
Brescia, Italy
Not Yet Recruiting
4
UOC Chirurgia Pediatrica ARNAS Garibaldi, Catania
Catania, Italy
Not Yet Recruiting
5
Chirurgia pediatrica P.O. "V.Fazzi"
Lecce, Italy
Not Yet Recruiting
6
Policlinico di Modena
Modena, Italy
Not Yet Recruiting
7
Ospedale Maggiore della Carità di Novara
Novara, Italy
Not Yet Recruiting
8
Ospedale universitario di Padova
Padova, Italy
Not Yet Recruiting
9
Policlinico Universitario Paolo Giaccone di Palermo
Palermo, Italy
Not Yet Recruiting
10
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Not Yet Recruiting
11
PO: Santo Spirito
Pescara, Italy
Not Yet Recruiting
12
A.O.R. "S. Carlo" - Potenza
Potenza, Italy
Not Yet Recruiting
13
AUSL della Romagna - Ospedale Infermi Rimini
Rimini, Italy
Not Yet Recruiting
14
Azienda Ospedaliera S.Camillo-Forlanini
Roma, Italy
Not Yet Recruiting
15
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Not Yet Recruiting
16
Ospedale Pediatrico Bambino Gesù
Roma, Italy
Not Yet Recruiting
17
Aou Senese
Siena, Italy
Not Yet Recruiting
18
Ospedale infantile Regina Margherita di Torino
Torino, Italy
Not Yet Recruiting
19
S. Antonio Abate - Trapani
Trapani, Italy
Not Yet Recruiting
20
Ospedale Filippo Del Ponte - Varese
Varese, Italy
Not Yet Recruiting
21
Azienda Ospedaliera Universitaria Verona
Verona, Italy
Not Yet Recruiting
Research Team
R
Riccardo Coletta
CONTACT
L
Lucia Paolini
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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