Comparing Conservative to Surgical Treatment of Trigonocephaly Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs
NCT ID: NCT06069479
Last Updated: 2025-08-11
Study Results
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Basic Information
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RECRUITING
440 participants
OBSERVATIONAL
2022-09-01
2031-08-31
Brief Summary
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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.
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Detailed Description
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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 CARE/COMPARISON 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 SIZE/DATA 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 (e.g., education). COST-EFFECTIVINESS ANALYSIS/BIA 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Conservative group
Children with trigonocephaly that are treated conservatively.
No interventions assigned to this group
Surgical group
Children with trigonocephaly that are treated surgically.
craniofacial surgery
Surgical treatment, either stripcraniectomy or fronto-orbital advancement
Interventions
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craniofacial surgery
Surgical treatment, either stripcraniectomy or fronto-orbital advancement
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
8 Years
ALL
No
Sponsors
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LAPOSA
UNKNOWN
IJsselland ziekenhuis
UNKNOWN
Sint Franciscus Gasthuis
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Irene Mathijssen
prof.dr. MBA-H
Principal Investigators
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Irene MJ Mathijssen, MD, PhD, MBA-H
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus MC
Rotterdam, ROTTERDAM, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Cornelissen MJ, Loudon SE, van Doorn FEC, Muller RPM, van Veelen MC, Mathijssen IMJ. Very Low Prevalence of Intracranial Hypertension in Trigonocephaly. Plast Reconstr Surg. 2017 Jan;139(1):97e-104e. doi: 10.1097/PRS.0000000000002866.
de Planque CA, Petr J, Gaillard L, Mutsaerts HJMM, van Veelen MC, Versnel SL, Dremmen MHG, Mathijssen IMJ. Cerebral Blood Flow of the Frontal Lobe in Untreated Children with Trigonocephaly versus Healthy Controls: An Arterial Spin Labeling Study. Plast Reconstr Surg. 2022 Apr 1;149(4):931-937. doi: 10.1097/PRS.0000000000008931.
Mathijssen IMJ; Working Group Guideline Craniosynostosis. Updated Guideline on Treatment and Management of Craniosynostosis. J Craniofac Surg. 2021 Jan-Feb 01;32(1):371-450. doi: 10.1097/SCS.0000000000007035. No abstract available.
Abdel-Alim T, Iping R, Wolvius EB, Mathijssen IMJ, Dirven CMF, Niessen WJ, van Veelen MC, Roshchupkin GV. Three-Dimensional Stereophotogrammetry in the Evaluation of Craniosynostosis: Current and Potential Use Cases. J Craniofac Surg. 2021 May 1;32(3):956-963. doi: 10.1097/SCS.0000000000007379.
Tio P, van Staalduinen M, Okkerse J, Dulfer K, Erler N, Loudon S, Telleman M, Abdel-Alim T, Roshchupkin G, Heemskerk S, Polinder S, van Veelen ML, Bannink N, van Driel A, Faasse M, Ista E, Joosten K, Spoor J, Weissbach E, Kats J, Versnel SL, Pleumeekers M, Mathijssen I. Comparing effectiveness of conservative policy to craniofacial surgery in children with metopic synostosis: protocol for an observational cohort study on clinical outcomes, psychosocial well-being and costs in a Dutch academic hospital. BMJ Open. 2025 May 6;15(5):e094112. doi: 10.1136/bmjopen-2024-094112.
Other Identifiers
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PaNaMaID 9517
Identifier Type: -
Identifier Source: org_study_id
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