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

NCT06069479 | Recruiting DMC

• 1 other identifier: PaNaMaID 9517
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Metopic Synostosis

Outcome Measures

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

  from 0 to 8 years old

Secondary Outcomes (6)

• fundoscopy

  from 1 to 4 years old

• Cognition and behavior

  at 0, 2, 4 and 8 years old

• refraction and vision

  at 1, 4 and 8 years old

• forehead shape

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

• Quality of life and post-traumatic stress

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

Study Arms (2)

Conservative group

Children with trigonocephaly that are treated conservatively.

Surgical group

Children with trigonocephaly that are treated surgically.

Procedure: craniofacial surgery

Interventions

craniofacial surgery PROCEDURE

Surgical treatment, either stripcraniectomy or fronto-orbital advancement

Surgical group

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• diagnosis of trigonocephaly

You may not qualify if:

• metopic ridge (physiologic early closure of metopic suture)

Sponsors & Collaborators

• Erasmus Medical Center: lead
• LAPOSA: collaborator
• IJsselland ziekenhuis: collaborator
• Sint Franciscus Gasthuis: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, ROTTERDAM, 3012LE, Netherlands

RECRUITING

Related Publications (5)

• 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.

  PMID: 28027242 BACKGROUND

• 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.

  PMID: 35171857 BACKGROUND

• 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.

  PMID: 33156164 BACKGROUND

• 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.

  PMID: 33405445 BACKGROUND

• 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.

  PMID: 40335143 DERIVED

MeSH Terms

Conditions

Craniosynostoses

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Irene MJ Mathijssen, MD, PhD, MBA-H

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene MJ Mathijssen, MD, PhD, MBA-H

CONTACT

+31655758441; i.mathijssen@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr. MBA-H

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 5, 2023
• Study Start: September 1, 2022
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): August 31, 2031
• Last Updated: August 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)