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Poor recruitment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic strip craniectomy with the use of lateral osteotomies | Active Comparator | Patients will have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture. |
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| Endoscopic strip craniectomy without the use of lateral osteotomies | Experimental | Patients will NOT have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy | Procedure | Endoscopic strip craniectomy is a surgical procedure performed to remove pathologic bone of the calvarium that includes the fused suture. Lateral osteotomies, also known as barrel-stave osteotomies, are performed by some surgeons because of their perceived benefit in regard to cranial expansion. Following surgery, orthotic helmet therapy is performed in order to mold the calvarium with the goals of optimizing contour. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David F Bauer, MD, MPH | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28409698 | Background | 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. | |
| 28841109 | Background |
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We have two patient groups. Group 1: Endoscopic strip craniectomy with the use of lateral osteotomies. Group 2: Endoscopic strip craniectomy without the use of lateral osteotomies.
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Participants and guardians of participants will not know which arm the participant is randomized to. Regarding care providers, only care providers performing the surgery will be privy to information regarding which arm the patient is randomized to.
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| Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy | Procedure | Endoscopic strip craniectomy is a surgical procedure performed to remove pathologic bone of the calvarium that includes the fused suture. Lateral osteotomies, also known as barrel-stave osteotomies, are performed by some surgeons because of their perceived benefit in regard to cranial expansion. Following surgery, orthotic helmet therapy is performed in order to mold the calvarium with the goals of optimizing contour. |
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| Operative length | Length of operation from incision to closure | during the intervention/procedure/surgery |
| Estimated Blood loss | Based on estimated volume of blood loss and perioperative changes in hemoglobin mass | during the intervention/procedure/surgery |
| Instance of transfusion | Whether or not the participant received a blood transfusion intraoperatively or post-operatively | during the intervention/procedure/surgery |
| Amount of blood transfused | Measured in mL/kg | during the intervention/procedure/surgery |
| Instance of dural tear | Whether or not the patient experienced a dural tear during surgery | during the intervention/procedure/surgery |
| 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 |
| Instance of needing further surgical correction | Whether or not the patient requires further surgical intervention to correct their calvarial defect. | 1 year after surgery |
| 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. |
| 28654600 | Background | 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. |
| ID | Term |
|---|---|
| D003398 | Craniosynostoses |
| ID | Term |
|---|---|
| D013580 | Synostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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