Clinical trial NCT04721769: Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis
Official title: Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Craniosynostosis, Sagittal
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 150
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in cephalic index from preoperative measurement to postoperative measurement at 1 year of age
timeFrame: Pre-operatively (at recruitment) & post-operatively (at 1 year of age)
Secondary outcomes:
measure: Aesthetic outcome
timeFrame: post-operatively (at 1 year of age)
measure: Operative length
timeFrame: during the intervention/procedure/surgery
measure: Estimated Blood loss
timeFrame: during the intervention/procedure/surgery
measure: Instance of transfusion
timeFrame: during the intervention/procedure/surgery
measure: Amount of blood transfused
timeFrame: during the intervention/procedure/surgery
measure: Instance of dural tear
timeFrame: during the intervention/procedure/surgery
measure: Instance of 30-day readmission
timeFrame: Day of procedure through 30 days post-operatively
measure: Instance of needing further surgical correction
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: David F Bauer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.