Anorectal MalformationsMAR-ITANCT07438691
Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study
An observational study of Anorectal Malformations, run by Meyer Children's Hospital IRCCS at 21 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- Anorectal Malformations
- How many people
- 500 participants
- Where
- 21 sitesItaly
- Study dates
- 5 Feb 2026to Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients (<18 years) diagnosed with anorectal malformation with perineal or vestibular fistula undergoing surgical correction between 2020 and 2027.
Who may be able to join
- 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
Who cannot join
- Age >18 years
- Other types of anorectal malformations
- Surgical technique other than those specified
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
Italy21 sites, 21 recruiting
- Not yet recruiting
ASST Papa Giovanni XXIII
Bergamo
Maurizio Cheli
- Not yet recruiting
Ospedale dei Bambini
Brescia
Anna Lavinia Bulotta
- Not yet recruiting
UOC Chirurgia Pediatrica ARNAS Garibaldi, Catania
Catania
Sebastiano Cacciaguerra
- Recruiting
Aou Meyer IRCSS
Florence, Florence, 50139
Riccardo Coletta, 390555662499, riccardo.coletta@meyer.it
- Not yet recruiting
Chirurgia pediatrica P.O. "V.Fazzi"
Lecce
Lucia Addolorata
- Not yet recruiting
Policlinico di Modena
Modena
Anastasia Bianchini
- Not yet recruiting
Ospedale Maggiore della Carità di Novara
Novara
Valerie Gabriele
- Not yet recruiting
Ospedale universitario di Padova
Padova
Miriam Duci
- Not yet recruiting
Policlinico Universitario Paolo Giaccone di Palermo
Palermo
Maria Rita Di Pace
- Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
Alessandro Raffaele
- Not yet recruiting
PO: Santo Spirito
Pescara
Gabriele Lisi
- Not yet recruiting
A.O.R. "S. Carlo" - Potenza
Potenza
Paolo Caia
- Not yet recruiting
AUSL della Romagna - Ospedale Infermi Rimini
Rimini
Francesco Italiano
- Not yet recruiting
Azienda Ospedaliera S.Camillo-Forlanini
Roma
Vito Briganti
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
Lorenzo Nanni
- Not yet recruiting
Ospedale Pediatrico Bambino Gesù
Roma
Conforti Andrea
- Not yet recruiting
Aou Senese
Siena
Rossella Angotti
- Not yet recruiting
Ospedale infantile Regina Margherita di Torino
Torino
Elisa Zambaiati
- Not yet recruiting
S. Antonio Abate - Trapani
Trapani
Paolo Formica
- Not yet recruiting
Ospedale Filippo Del Ponte - Varese
Varese
Mirella Mogiatti
- Not yet recruiting
Azienda Ospedaliera Universitaria Verona
Verona
Gabriella Scire
About this study
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.
Read the 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
- Keywords
- Anorectal Malformation, Perineal Fistula, Rectovestibular Fistula
- Medical subject headings
- Anorectal Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PSARP group | Patients undergoing posterior sagittal anorectoplasty (PSARP) or its variants (miniPSARP) | |
| TAP group | Patients undergoing transanal proctoplasty (TAP). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Continence at 3 YEARS
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
Measured: 3 years post-surgery
Fecal Continence at 6 Years
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
Measured: 6 years post-surgery
Secondary outcomes (5)
Postoperative Complications Within 30 Days
Presence and severity of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Madadi pediatric surgical complication grading system.
Measured: Within 30 days after surgical correction
ectal Mucosal Prolapse
Occurrence of rectal mucosal prolapse during follow-up, including frequency and need for medical or surgical treatment.
Measured: From surgery until 6 years of age or achievement of fecal continence (up to 6 years)
Quality of Life (HAQL Questionnaire)
The HAQL questionnaire evaluates disease-specific quality of life in patients with Hirschsprung's disease and anorectal malformations.
The questionnaire generates domain-specific scores and a total score ranging from 0 to 100, where higher scores indicate better quality of life.
Validated Italian age-specific versions of the HAQL questionnaire will be used when applicable.
Measured: Assessed annually until 6 years of age or achievement of fecal continence
Constipation Severity and Bowel Management Requirements
Presence and severity of constipation, including need for dietary measures, laxatives, enemas, or structured bowel management programs, evaluated according to the Krickenbeck criteria.
Measured: Assessed annually until 6 years of age or achievement of fecal continence
time to Achievement of Fecal Continence
Time from surgical correction to achievement of fecal continence, defined according to the Krickenbeck score (voluntary bowel movements, ability to verbalize urge, and absence of significant soiling).
Measured: From date of surgery until continence is achieved or up to 6 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start5 Feb 2026
- Primary completionFeb 2033 (estimated)
- Study completionFeb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal MalformationsStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Coletta, Meyer Children's Hospital IRCCS
- Investigators
- Riccardo Coletta, Principal investigator, Meyer IRCSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438691
- Sponsor's protocol ID
- MAR-ITA
- Acronym
- MAR-ITA
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study
- ClinicalTrials.gov ID
- NCT07438691
- Acronym / sponsor ID
- MAR-ITA / MAR-ITA
- Conditions
- Anorectal Malformations
- Keywords
- Anorectal Malformation, Perineal Fistula, Rectovestibular Fistula
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- Feb 2033 (estimated)
- Study completion
- Feb 2033 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSARP group | – | –Patients undergoing posterior sagittal anorectoplasty (PSARP) or its variants (miniPSARP) |
| TAP group | – | –Patients undergoing transanal proctoplasty (TAP). |
Who may qualify
- Ages
- 0 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients (<18 years) diagnosed with anorectal malformation with perineal or vestibular fistula undergoing surgical correction between 2020 and 2027.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age >18 years
- Other types of anorectal malformations
- Surgical technique other than those specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fecal Continence at 3 YEARS
Time frame: 3 years post-surgery
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
Fecal Continence at 6 Years
Time frame: 6 years post-surgery
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Riccardo Coletta principal investigator
Meyer IRCSS
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorectal Malformations, run by Meyer Children's Hospital IRCCS at 21 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Coletta (390555662499, riccardo.coletta@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal Continence at 3 YEARS (time frame: 3 years post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.