Craniosynostosis, Sagittal Clinical Trial
Official title:
Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis
- 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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Fearon JA, Ditthakasem K, Herbert M, Kolar J. An Appraisal of the Cephalic Index in Sagittal Craniosynostosis, and the Unseen Third Dimension. Plast Reconstr Surg. 2017 Jul;140(1):138-145. doi: 10.1097/PRS.0000000000003422. — View Citation
Nguyen DC, Farber SJ, Skolnick GB, Naidoo SD, Smyth MD, Kane AA, Patel KB, Woo AS. One hundred consecutive endoscopic repairs of sagittal craniosynostosis: an evolution in care. J Neurosurg Pediatr. 2017 Nov;20(5):410-418. doi: 10.3171/2017.5.PEDS16674. Epub 2017 Aug 25. — View Citation
Wood BC, Ahn ES, Wang JY, Oh AK, Keating RF, Rogers GF, Magge SN. Less is more: does the addition of barrel staves improve results in endoscopic strip craniectomy for sagittal craniosynostosis? J Neurosurg Pediatr. 2017 Jul;20(1):86-90. doi: 10.3171/2017.1.PEDS16478. Epub 2017 Apr 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cephalic index from preoperative measurement to postoperative measurement at 1 year of age | The cephalic index is the ratio of maximal head width and length. Patients enrolled in the trial will undergo pre-operative and post-operative measurement of their cephalic index using the STARscanner© (Orthomerica products Inc.). Patients will undergo measurement at recruitment and at 1 year of age. | Pre-operatively (at recruitment) & post-operatively (at 1 year of age) | |
Secondary | Aesthetic outcome | The aesthetic appearance of the calvarium will be measured by participating surgeons using a 5-point Likert scale (1-5) with 1 being extremely satisfied with aesthetic outcome and 5 being extremely dissatisfied with aesthetic outcome. Surgeons that are aware of the participant's assignment are excluded from this portion of the study to minimize bias. | post-operatively (at 1 year of age) | |
Secondary | Operative length | Length of operation from incision to closure | during the intervention/procedure/surgery | |
Secondary | Estimated Blood loss | Based on estimated volume of blood loss and perioperative changes in hemoglobin mass | during the intervention/procedure/surgery | |
Secondary | Instance of transfusion | Whether or not the participant received a blood transfusion intraoperatively or post-operatively | during the intervention/procedure/surgery | |
Secondary | Amount of blood transfused | Measured in mL/kg | during the intervention/procedure/surgery | |
Secondary | Instance of dural tear | Whether or not the patient experienced a dural tear during surgery | during the intervention/procedure/surgery | |
Secondary | Instance of 30-day readmission | Whether or not a patient was readmitted to the hospital for complications related to their surgical procedure | Day of procedure through 30 days post-operatively | |
Secondary | Instance of needing further surgical correction | Whether or not the patient requires further surgical intervention to correct their calvarial defect. | 1 year after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06294626 -
Examination of Neuromotor Development of Cases Diagnosed With Scaphocephaly
|