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Comparing Conservative to Surgical Treatment of Trigonocephaly Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs

NCT06069479 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 440

Last updated 2025-08-11

No results posted yet for this study

Summary

RESEARCH QUESTION Is the effectiveness of conservative policy comparable to that of surgery in children with trigonocephaly, with regard to clinical outcomes and psychosocial functioning, stress for parents, and costs? DESIGN Observational cohort study in children, aged 0 to 8 years old, with trigonocephaly, excluding metopic ridging (physiologic early closure of metopic suture), treated conservatively or surgically.

OUTCOME MEASURES Primary: Head growth decline, indicating raised intracranial pressure Secondary: fundoscopy, cognition, behavior, refraction and vision, forehead shape, quality of life, posttraumatic stress, decisional conflict, costs.

Conditions

  • Metopic Synostosis

Interventions

PROCEDURE

craniofacial surgery

Surgical treatment, either stripcraniectomy or fronto-orbital advancement

Sponsors & Collaborators

  • LAPOSA

    collaborator UNKNOWN

  • IJsselland ziekenhuis

    collaborator UNKNOWN

  • Sint Franciscus Gasthuis

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Irene MJ Mathijssen, MD, PhD, MBA-H · Erasmus Medical Center

Eligibility

Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2031-02-28
Completion
2031-08-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06069479 on ClinicalTrials.gov