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NCT Number: NCT07438691

Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian 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.

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Key information

Conditions

Anorectal Malformations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases

Age range

0 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aou Meyer IRCSS, Florence, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fecal Continence at 3 YEARS

    Time frame: 3 years post-surgery

    Measured by proportion of children achieving fecal continence according to Krickenbeck score.

  2. Fecal Continence at 6 Years

    Time frame: 6 years post-surgery

    Measured by proportion of children achieving fecal continence according to Krickenbeck score.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lucia Paolini

CONTACT

[email protected]

390555662499

Riccardo Coletta

CONTACT

[email protected]

390555662499

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Acronym: MAR-ITA

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Feb 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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