Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Baylor College of Medicine
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Change in cephalic index from preoperative measurement to postoperative measurement at 1 year of age
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- — to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Endoscopic strip craniectomy with the use of lateral osteotomies
Patients will have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture.
Intervention: Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy (Procedure)
Endoscopic strip craniectomy without the use of lateral osteotomies
Patients will NOT have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture.
Intervention: Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy (Procedure)
Outcomes
Primary Outcomes
Change in cephalic index from preoperative measurement to postoperative measurement at 1 year of age
Time Frame: 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 Outcomes
- Instance of transfusion(during the intervention/procedure/surgery)
- Amount of blood transfused(during the intervention/procedure/surgery)
- Instance of needing further surgical correction(1 year after surgery)
- Operative length(during the intervention/procedure/surgery)
- Estimated Blood loss(during the intervention/procedure/surgery)
- Instance of dural tear(during the intervention/procedure/surgery)
- Aesthetic outcome(post-operatively (at 1 year of age))
- Instance of 30-day readmission(Day of procedure through 30 days post-operatively)
Investigators
David Bauer
Principal Investigator
Baylor College of Medicine