Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis
- Conditions
- Craniosynostosis, Sagittal
- Interventions
- Procedure: Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapyProcedure: Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy
- Registration Number
- NCT04721769
- Lead Sponsor
- Baylor College of Medicine
- 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.
* Both arms of the study will undergo standard care throughout their participation which includes preoperative \& postoperative measurements of cephalic index using the STARscanner© (Orthomerica products Inc.), preoperative \& postoperative photographs, post-operative helmeting, and standard post-operative visits.
* 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- All patients with isolated, non-syndromic sagittal craniosynostosis under 6 months of age who present to Texas Children's Hospital.
- Patients who are unable to undergo endoscopic strip craniectomy by 6 months of age.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endoscopic strip craniectomy without the use of lateral osteotomies Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy Patients will NOT have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture. Endoscopic strip craniectomy with the use of lateral osteotomies Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy Patients will have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture.
- Primary Outcome Measures
Name Time Method Change in cephalic index from preoperative measurement to postoperative measurement at 1 year of age Pre-operatively (at recruitment) & post-operatively (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.
- Secondary Outcome Measures
Name Time Method Instance of transfusion during the intervention/procedure/surgery Whether or not the participant received a blood transfusion intraoperatively or post-operatively
Amount of blood transfused during the intervention/procedure/surgery Measured in mL/kg
Instance of needing further surgical correction 1 year after surgery Whether or not the patient requires further surgical intervention to correct their calvarial defect.
Operative length during the intervention/procedure/surgery Length of operation from incision to closure
Estimated Blood loss during the intervention/procedure/surgery Based on estimated volume of blood loss and perioperative changes in hemoglobin mass
Instance of dural tear during the intervention/procedure/surgery Whether or not the patient experienced a dural tear during surgery
Aesthetic outcome post-operatively (at 1 year of age) 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.
Instance of 30-day readmission Day of procedure through 30 days post-operatively Whether or not a patient was readmitted to the hospital for complications related to their surgical procedure
Trial Locations
- Locations (1)
Texas Children's Hospital
🇺🇸Houston, Texas, United States