Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06069479
Status:
RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-10-02
Brief Title:
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
Organization:
Erasmus Medical Center
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Treat Trigono
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 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
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
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 POPULATION Children aged 0 to 8 years old with trigonocephaly excluding metopic ridging physiologic early closure of metopic suture INTERVENTION Conservative policy USUAL CARECOMPARISON Craniofacial surgery OUTCOME MEASURES Primary Head growth decline head circumference in SD indicating raised intracranial pressure Secondary fundoscopy cognition behavior refraction and vision forehead shape quality of life posttraumatic stress decisional conflict costs Repeated measures at 0 2 4 6 8 years of age SAMPLE SIZEDATA ANALYSIS Eligible patients 3 years of age are included since Sept 2022 Sample size 440 patients 1 year of age 195 surgery and 245 conservative
Non-inferiority with regard to head growth from 0-4 years annual measurement is determined using a linear mixed model adjusted for confounders
severity of phenotype sex syndrome and parental factors eg education COST-EFFECTIVINESS ANALYSISBIA An economic evaluation is performed with the incorporation of medical costs and costs due to loss of productivity for the parents A detailed costs-study is done for medical specialist care surgical costs hospitalization and other costs directly associated with the interventions Cost prizes of surgery will be determined by the bottom-up micro-costing method Cost-utility will be measured with QALY based on EQ-5D utility score gained with confidence ellipses and acceptability curves The impact of conservative policy versus surgery will be investigated on assurance perspective and central level From the viewpoint of the health care government a societal perspective and perspective of the budgettair kader zorg will be highlighted We will provide a valid framework with budget consequences by a range of predictions Sensitivity analysis is done
TIME SCHEDULE Inclusion between Sept 2022 and Sept 2030 Analysis and reporting for each outcome parameter related to age is distributed from January 2025 to September 2031 New recommendation for treatment of trigonocephaly in guideline ready in 2031
STUDY DESIGN Observational cohort study STUDY POPULATION Children aged 0 to 8 years old with trigonocephaly excluding metopic ridging physiologic early closure of metopic suture INTERVENTION Conservative policy USUAL CARECOMPARISON Craniofacial surgery OUTCOME MEASURES Primary Head growth decline head circumference in SD indicating raised intracranial pressure Secondary fundoscopy cognition behavior refraction and vision forehead shape quality of life posttraumatic stress decisional conflict costs Repeated measures at 0 2 4 6 8 years of age SAMPLE SIZEDATA ANALYSIS Eligible patients 3 years of age are included since Sept 2022 Sample size 440 patients 1 year of age 195 surgery and 245 conservative
Non-inferiority with regard to head growth from 0-4 years annual measurement is determined using a linear mixed model adjusted for confounders
severity of phenotype sex syndrome and parental factors eg education COST-EFFECTIVINESS ANALYSISBIA An economic evaluation is performed with the incorporation of medical costs and costs due to loss of productivity for the parents A detailed costs-study is done for medical specialist care surgical costs hospitalization and other costs directly associated with the interventions Cost prizes of surgery will be determined by the bottom-up micro-costing method Cost-utility will be measured with QALY based on EQ-5D utility score gained with confidence ellipses and acceptability curves The impact of conservative policy versus surgery will be investigated on assurance perspective and central level From the viewpoint of the health care government a societal perspective and perspective of the budgettair kader zorg will be highlighted We will provide a valid framework with budget consequences by a range of predictions Sensitivity analysis is done
TIME SCHEDULE Inclusion between Sept 2022 and Sept 2030 Analysis and reporting for each outcome parameter related to age is distributed from January 2025 to September 2031 New recommendation for treatment of trigonocephaly in guideline ready in 2031
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None