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

March 23, 2026 updated by: Riccardo Coletta, Meyer Children's Hospital IRCCS

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bergamo, Italy
        • Not yet recruiting
        • ASST Papa Giovanni XXIII
        • Contact:
          • Maurizio Cheli
      • Brescia, Italy
        • Not yet recruiting
        • Ospedale dei Bambini
        • Contact:
          • Anna Lavinia Bulotta
      • Catania, Italy
        • Not yet recruiting
        • UOC Chirurgia Pediatrica ARNAS Garibaldi, Catania
        • Contact:
          • Sebastiano Cacciaguerra
      • Lecce, Italy
        • Not yet recruiting
        • Chirurgia pediatrica P.O. "V.Fazzi"
        • Contact:
          • Lucia Addolorata
      • Modena, Italy
        • Not yet recruiting
        • Policlinico di Modena
        • Contact:
          • Anastasia Bianchini
      • Novara, Italy
        • Not yet recruiting
        • Ospedale Maggiore della Carità di Novara
        • Contact:
          • Valerie Gabriele
      • Padua, Italy
        • Not yet recruiting
        • Ospedale universitario di Padova
        • Contact:
          • Miriam Duci
      • Palermo, Italy
        • Not yet recruiting
        • Policlinico Universitario Paolo Giaccone di Palermo
        • Contact:
          • Maria Rita Di Pace
      • Pavia, Italy
        • Not yet recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:
          • Alessandro Raffaele
      • Pescara, Italy
        • Not yet recruiting
        • PO: Santo Spirito
        • Contact:
          • Gabriele Lisi
      • Potenza, Italy
        • Not yet recruiting
        • A.O.R. "S. Carlo" - Potenza
        • Contact:
          • Paolo Caia
      • Rimini, Italy
        • Not yet recruiting
        • AUSL della Romagna - Ospedale Infermi Rimini
        • Contact:
          • Francesco Italiano
      • Roma, Italy
        • Not yet recruiting
        • Ospedale Pediatrico Bambino Gesu
        • Contact:
          • Conforti Andrea
      • Roma, Italy
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
          • Lorenzo Nanni
      • Roma, Italy
        • Not yet recruiting
        • Azienda Ospedaliera S.Camillo-Forlanini
        • Contact:
          • Vito Briganti
      • Siena, Italy
        • Not yet recruiting
        • AOU Senese
        • Contact:
          • Rossella Angotti
      • Torino, Italy
        • Not yet recruiting
        • Ospedale infantile Regina Margherita di Torino
        • Contact:
          • Elisa Zambaiati
      • Trapani, Italy
        • Not yet recruiting
        • S. Antonio Abate - Trapani
        • Contact:
          • Paolo Formica
      • Varese, Italy
        • Not yet recruiting
        • Ospedale Filippo Del Ponte - Varese
        • Contact:
          • Mirella Mogiatti
      • Verona, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Verona
        • Contact:
          • Gabriella Scire
    • Florence
      • Florence, Florence, Italy, 50139

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients (<18 years) diagnosed with anorectal malformation with perineal or vestibular fistula undergoing surgical correction between 2020 and 2027.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PSARP group
Patients undergoing posterior sagittal anorectoplasty (PSARP) or its variants (miniPSARP)
TAP group
Patients undergoing transanal proctoplasty (TAP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal Continence at 3 YEARS
Time Frame: 3 years post-surgery
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
3 years post-surgery
Fecal Continence at 6 Years
Time Frame: 6 years post-surgery
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
6 years post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications Within 30 Days
Time Frame: Within 30 days after surgical correction
Presence and severity of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Madadi pediatric surgical complication grading system.
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)
Occurrence of rectal mucosal prolapse during follow-up, including frequency and need for medical or surgical treatment.
From surgery until 6 years of age or achievement of fecal continence (up to 6 years)
Constipation Severity and Bowel Management Requirements
Time Frame: Assessed annually until 6 years of age or achievement of fecal continence
Presence and severity of constipation, including need for dietary measures, laxatives, enemas, or structured bowel management programs, evaluated according to the Krickenbeck criteria.
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
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).
From date of surgery until continence is achieved or up to 6 years of age
Quality of Life (HAQL Questionnaire)
Time Frame: Assessed annually until 6 years of age or achievement of fecal continence

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.
Assessed annually until 6 years of age or achievement of fecal continence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Investigators

  • Principal Investigator: Riccardo Coletta, Meyer IRCSS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Estimated)

February 1, 2033

Study Completion (Estimated)

February 1, 2033

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAR-ITA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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