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RECRUITING
NCT06069479

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

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

craniofacial surgery

Surgical treatment, either stripcraniectomy or fronto-orbital advancement

Locations (1)

Erasmus MC

Rotterdam, ROTTERDAM, Netherlands