Observational Study Comparing Conservative Treatment and Craniofacial Surgery for Children Aged 0 to 8 Years With Trigonocephaly Assessing Clinical Outcomes, Psychosocial Wellbeing, and Costs

What this Trial Is About

Researchers are studying children aged 0 to 8 years old with trigonocephaly, a condition affecting the shape of the head. This observational cohort study compares the outcomes of conservative treatment versus craniofacial surgery, focusing on clinical results, psychosocial wellbeing, stress experienced by parents, and costs. The study aims to determine whether conservative treatment is as effective as surgery while causing less burden and being more cost-effective. The study involves two groups children treated conservatively and those who undergo craniofacial surgery, which includes procedures like strip craniectomy or fronto-orbital advancement. Measurements and evaluations are taken repeatedly at ages 0, 2, 4, 6, and 8 years to track head growth and other health aspects. Participants are assessed through various methods including head circumference measurements to monitor intracranial pressure, eye exams fundoscopy, cognitive and behavioral tests, vision and refraction checks, forehead shape evaluations, quality of life and stress questionnaires, and decisional conflict assessments at age 8. The study also analyzes medical and parental productivity costs. Data collection will continue until 2031, with findings aimed to inform future treatment guidelines for trigonocephaly.

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