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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 8
SponsorErasmus Medical Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • craniofacial surgery

    Procedure/Surgery

    Surgical treatment, either stripcraniectomy or fronto-orbital advancement

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Conservative group0 interventions
Group B: Surgical group1 intervention

Trial outcomes

Primary outcomes

1

Head growth

Annual measurement of head circumference in SD for gender and age. Decline in head growth may indicate raised intracranial pressure

Time frame
from 0 to 8 years old

Secondary outcomes

1

fundoscopy

Annual screening for presence of papilledema as sign of raised intracranial pressure

Time frame
from 1 to 4 years old
2

Cognition and behavior

Validated tests for cognition and behavior of the child

Time frame
at 0, 2, 4 and 8 years old
3

refraction and vision

tests taken by orthoptist

Time frame
at 1, 4 and 8 years old
4

forehead shape

3D photos (objective) and VAS score by parents (subjective) to grade the forehead shape

Time frame
at 0, 2, 4, 6 and 8 years old

Other outcomes

Sponsors and contacts

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Erasmus Medical Center

Lead sponsor

LAPOSA

Collaborator

IJsselland Hospital

Collaborator

Sint Franciscus Gasthuis

Collaborator