Clinical Study on Improvement of Peritoneal Catheter Placement in Ventriculoperitoneal Shunt Surgery With a Splitable Trocar
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of shunt failure
研究概览
简要总结
This study is a phase I/IIa, single-center, open-labeled, randomized, controlled clinical trial. The aim of this study is to evaluate the safety and efficacy of a modified ventriculoperitoneal catheter placement using a splitable trocar for ventriculoperitoneal shunt.
详细描述
This study is a phase I/IIa, single-center, open-labeled, randomized, controlled clinical trial. Patients hospitalized with hydrocephalus will be enrolled and randomly allocated into open mini-laparotomy group (OLG) or abdominal puncture group (APG) for insertion of the peritoneal catheter. Observe will followed for up to at least 6 months after surgery. The primary endpoint is the rate of overall shunt complication or failure within the first 6 months after surgery, and duration of the abdominal catheterization. The secondary endpoints are rate of distal shunt failure, the overall incidence of various adverse reactions, abdominal incision size, analgesic use as evaluated on Day 5 postoperatively, duration of hospital stay. Moreover, neurological function of patients (mRS, maxillary hydrocephalus scale) and CT measurement of Even index will also be evaluated.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older with new-onset hydrocephalus, including obstructive hydrocephalus, traffic hydrocephalus and special types of hydrocephalus, normal pressure hydrocephalus (NPH), idiopathic intracranial hypertension (IIH), benign intracranial hypertension, pseudotumor cerebri, etc., regardless of gender.
- •Initial diagnosis of hydrocephalus requiring ventriculoperitoneal shunt or shunt failure requiring secondary surgery to replace the shunt.
- •Provided written informed consent.
排除标准
- •Previous abdominal surgery (except ventriculoperitoneal shunt).
- •Peritonitis
- •Patients with cognitive impairment and inability to communicate.
- •Expected survival less than 6 months
结局指标
主要结局
Rate of shunt failure
时间窗: 6 months
Overall rate of shunt failure requiring revision
Duration of the abdominal catheterization
时间窗: During the surgery
Duration of the abdominal catheterization, defined as the time from abdominal incision to abdominal skin suture completed.
次要结局
- The incidence of anargesic drug use(Day 5 after surgery)
- Rate of distal shunt failure(6 months)
- Abdominal incision size(During the surgery)
- The incidence of adverse reactions(6 months)
- Duration of hospita stay(During perioperative period)
研究者
Zhen-Zhou Chen
Clinical Professor
Southern Medical University, China