NCT04721769终止不适用
Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in cephalic index from preoperative measurement to postoperative measurement at 1 year of age
研究概览
简要总结
- 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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with isolated, non-syndromic sagittal craniosynostosis under 6 months of age who present to Texas Children's Hospital.
排除标准
- •Patients who are unable to undergo endoscopic strip craniectomy by 6 months of age.
结局指标
主要结局
Change in cephalic index from preoperative measurement to postoperative measurement at 1 year of age
时间窗: 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.
次要结局
- 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)
研究者
David Bauer
Principal Investigator
Baylor College of Medicine
研究点 (2)
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