Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis
Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis
ClinicalTrials.gov ID
NCT04721769
Lead Sponsor
Baylor College of MedicineOTHER
Overall Status
Terminated
Study Type
Interventional
Phase
Not Applicable
Enrollment
6Actual
Last Update Posted
Sep 19, 2025Actual
Start Date
Dec 18, 2020Actual
Primary Completion Date
May 1, 2025Actual
Completion Date
May 1, 2025Actual
Official Title
Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis
Brief Summary
Endoscopic strip craniectomy (ESC) with post-operative helmeting is the gold-standard treatment for isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age as it is has been demonstrated to reduce perioperative morbidity when compared to more invasive procedures such as cranial vault remodeling. ESC is frequently performed with or without the use of lateral osteotomies with technical selection being largely based on surgeon preference.
Previous studies have shown that there are no statistically significant differences in cranial expansion or complications between the two procedure variants; however, these studies are retrospective in nature and do not account for aesthetic outcomes.
The purpose of this study is to compare the efficacy of ESC with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis. In addition, we seek to investigate if there are any observable changes in perioperative morbidity between the two procedures.
Detailed Description
This prospective, randomized parallel study seeks to compare the efficacy of ESC with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis.
Additional research-related activities include chart review. Primary outcomes include degree of cranial expansion at 1 year post-operatively.
Secondary outcomes include aesthetic appearance at 1 year post-operatively (using a 5-point Likert scale) and a multitude of intraoperative clinical variables including estimated blood loss, instances of transfusion, instances of dural tear, instances of 30-day readmission, and instances of needing further surgery.
Craniosynostosis, Sagittal
Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy
Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy
Ages Eligible for Study
Child (0-17)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with isolated, non-syndromic sagittal craniosynostosis under 6 months of age who present to Texas Children's Hospital.
Exclusion Criteria:
Patients who are unable to undergo endoscopic strip craniectomy by 6 months of age.