About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of trigonocephaly
Disqualifiers
metopic ridge (physiologic early closure of metopic suture)
Trial population
Children with mild, moderate or severe trigonocephaly, between 0 and 8 years of age, excluding metopic ridge (i.e. physiologic early closure of metopic suture).
Trial design
Cohort
Prospective
Treatments tested in this trial
craniofacial surgery
Procedure/SurgerySurgical treatment, either stripcraniectomy or fronto-orbital advancement
Treatment groups
Trial outcomes
Primary outcomes
Head growth
Annual measurement of head circumference in SD for gender and age. Decline in head growth may indicate raised intracranial pressure
Secondary outcomes
fundoscopy
Annual screening for presence of papilledema as sign of raised intracranial pressure
Cognition and behavior
Validated tests for cognition and behavior of the child
refraction and vision
tests taken by orthoptist
forehead shape
3D photos (objective) and VAS score by parents (subjective) to grade the forehead shape
Sponsors and contacts
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Erasmus Medical Center
Lead sponsor
LAPOSA
Collaborator
IJsselland Hospital
Collaborator
Sint Franciscus Gasthuis
Collaborator