Whitehead William E, Riva-Cambrin Jay, Wellons John C, Kulkarni Abhaya V, Limbrick David D, Wall Vanessa L, Rozzelle Curtis J, Hankinson Todd C, McDonald Patrick J, Krieger Mark D, Pollack Ian F, Tamber Mandeep S, Pindrik Jonathan, Hauptman Jason S, Naftel Robert P, Shannon Chevis N, Chu Jason, Jackson Eric M, Browd Samuel R, Simon Tamara D, Holubkov Richard, Reeder Ron W, Jensen Hailey, Koschnitzky Jenna E, Gross Paul, Drake James M, Kestle John R W
1Department of Neurosurgery, Baylor College of Medicine, Houston, Texas.
2Department of Neurosurgery, University of Calgary, Calgary, Alberta, Canada.
J Neurosurg Pediatr. 2021 Nov 19;29(3):257-267. doi: 10.3171/2021.9.PEDS21391. Print 2022 Mar 1.
The primary objective of this trial was to determine if shunt entry site affects the risk of shunt failure.
The authors performed a parallel-design randomized controlled trial with an equal allocation of patients who received shunt placement via the anterior entry site and patients who received shunt placement via the posterior entry site. All patients were children with symptoms or signs of hydrocephalus and ventriculomegaly. Patients were ineligible if they had a prior history of shunt insertion. Patients received a ventriculoperitoneal shunt after randomization; randomization was stratified by surgeon. The primary outcome was shunt failure. The planned minimum follow-up was 18 months. The trial was designed to achieve high power to detect a 10% or greater absolute difference in the shunt failure rate at 1 year. An independent, blinded adjudication committee determined eligibility and the primary outcome. The study was conducted by the Hydrocephalus Clinical Research Network.
The study randomized 467 pediatric patients at 14 tertiary care pediatric hospitals in North America from April 2015 to January 2019. The adjudication committee, blinded to intervention, excluded 7 patients in each group for not meeting the study inclusion criteria. For the primary analysis, there were 229 patients in the posterior group and 224 patients in the anterior group. The median patient age was 1.3 months, and the most common etiologies of hydrocephalus were postintraventricular hemorrhage secondary to prematurity (32.7%), myelomeningocele (16.8%), and aqueductal stenosis (10.8%). There was no significant difference in the time to shunt failure between the entry sites (log-rank test, stratified by age < 6 months and ≥ 6 months; p = 0.061). The hazard ratio (HR) of a posterior shunt relative to an anterior shunt was calculated using a univariable Cox regression model and was nonsignificant (HR 1.35, 95% CI, 0.98-1.85; p = 0.062). No significant difference was found between entry sites for the surgery duration, number of ventricular catheter passes, ventricular catheter location, and hospital length of stay. There were no significant differences between entry sites for intraoperative complications, postoperative CSF leaks, pseudomeningoceles, shunt infections, skull fractures, postoperative seizures, new-onset epilepsy, or intracranial hemorrhages.
This randomized controlled trial comparing the anterior and posterior shunt entry sites has demonstrated no significant difference in the time to shunt failure. Anterior and posterior entry site surgeries were found to have similar outcomes and similar complication rates.
本试验的主要目的是确定分流管置入部位是否会影响分流失败的风险。
作者进行了一项平行设计的随机对照试验,将通过前入路置入分流管的患者和通过后入路置入分流管的患者进行等量分配。所有患者均为有脑积水和脑室扩大症状或体征的儿童。有分流管置入既往史的患者不符合入选标准。患者随机分组后接受脑室腹腔分流术;随机分组按外科医生进行分层。主要结局是分流失败。计划的最短随访时间为18个月。该试验旨在具备足够的检验效能,以检测1年时分流失败率存在10%或更大的绝对差异。一个独立的、盲法判定委员会确定入选资格和主要结局。该研究由脑积水临床研究网络开展。
2015年4月至2019年1月,在北美的14家三级儿科医疗中心,该研究将467例儿科患者进行了随机分组。判定委员会在不知道干预措施的情况下,每组排除了7例不符合研究纳入标准的患者。对于主要分析,后入路组有229例患者,前入路组有224例患者。患者的中位年龄为1.3个月,脑积水最常见的病因是早产继发脑室内出血(32.7%)、脊髓脊膜膨出(16.8%)和导水管狭窄(10.8%)。入路部位之间在分流失败时间上无显著差异(对数秩检验,按年龄<6个月和≥6个月分层;p = 0.061)。使用单变量Cox回归模型计算后入路分流相对于前入路分流的风险比(HR),结果无统计学意义(HR 1.35,95%CI,0.98 - 1.85;p = 0.062)。手术持续时间、脑室导管穿刺次数、脑室导管位置及住院时间在入路部位之间未发现显著差异。术中并发症、术后脑脊液漏、假性脑膜膨出、分流感染、颅骨骨折、术后癫痫发作、新发癫痫或颅内出血在入路部位之间均无显著差异。
这项比较前入路和后入路分流部位的随机对照试验表明,分流失败时间无显著差异。发现前入路和后入路手术的结局相似,并发症发生率也相似。