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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
Sponsor: Erasmus Medical Center
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.
Official title: Comparing Effectiveness of a Conservative Policy to Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs
Key Details
Gender
All
Age Range
Any - 8 Years
Study Type
OBSERVATIONAL
Enrollment
440
Start Date
2022-09-01
Completion Date
2031-08-31
Last Updated
2025-08-11
Healthy Volunteers
No
Conditions
Interventions
craniofacial surgery
Surgical treatment, either stripcraniectomy or fronto-orbital advancement
Locations (1)
Erasmus MC
Rotterdam, ROTTERDAM, Netherlands