Status:
RECRUITING
Comparing Conservative to Surgical Treatment of Trigonocephaly Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
LAPOSA
IJsselland ziekenhuis
Conditions:
Metopic Synostosis
Eligibility:
All Genders
Up to 8 years
Brief 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 p...
Detailed Description
HYPOTHESIS Conservative treatment is non-inferior to surgery with regard to clinical outcomes, causes less burden of disease, and is cost-effective. STUDY DESIGN Observational cohort study STUDY POPU...
Eligibility Criteria
Inclusion
- diagnosis of trigonocephaly
Exclusion
- metopic ridge (physiologic early closure of metopic suture)
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2031
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT06069479
Start Date
September 1 2022
End Date
August 31 2031
Last Update
August 11 2025
Active Locations (1)
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1
Erasmus MC
Rotterdam, ROTTERDAM, Netherlands, 3012LE