Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- surgical intervention time (minutes)
研究概览
简要总结
This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt (VPS) placement to stereotactic navigation in a randomized controlled fashion with the surgical intervention time as primary outcome. All patients entering the University Hospital of Basel for elective or emergent VPS surgery will be randomized in 1:1 fashion to one of the study groups at admission or the day before the operation.
详细描述
Ventriculoperitoneal shunt (VPS) placement is one of the most frequent procedures in neurosurgical practice. The position of the proximal ventricular catheter is important since it influences possible malfunction of the VPS. For the improvement of accuracy in proximal VPS placement, navigation-based insertion techniques have been developed. VPS placement using stereotactic navigation has shown a high accuracy of catheter placement been developed. VPS placement using stereotactic navigation has shown a high accuracy of catheter placement, while the main limitations are that for referencing, the head of the patient needs to be fixed in a head holder and the preoperative set-up can be time-consuming. US-G VPS placement using a burr hole probe was described as an alternate for image-guided VPS placement technique. For US-G VPS placement head fixation or preoperative registration is not needed. This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt (VPS) placement to stereotactic navigation in a randomized controlled fashion with the surgical intervention time as primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The primary outcome is the surgical intervention time, recorded by blinded anaesthesiologists. Some of the secondary outcomes (catheter placement (optimal vs. not optimal, grade I to IV), volumetry of side ventricles, Evans' Index) are measured by a blinded neuroradiologist.
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
- •Informed Consent as documented by signature
- •Patients undergoing elective or emergent VPS placement (frontal or occipital shunt )
排除标准
- •Revision surgery due to former VPS placement using the same side and location for VPS placement or when no complete shunt is revised (proximal and distal), resulting in a shorter operation time
- •Ventriculoatrial or ventriculopleural Placement
- •Women who are pregnant or breast feeding
- •Intention to become pregnant during the course of the study
- •Previous enrolment into the current study
- •Enrolment of the investigator, his/her family members, employees, and other dependent persons
结局指标
主要结局
surgical intervention time (minutes)
时间窗: at Operation day (V2, up to 24 hours)
time spent in the Operating Room (OR) by the surgeon, includes preparation time together (patient positioning, head clamping in the stereotactic navigation group) with the operation time of the neurosurgical part. Beginning ("positioning") and ending ("suture neurosurgical part") of this time interval is clearly defined and will be in a standardized manner recorded by blinded anaesthesiologists. . In the stereotactic navigation group, an additional 5 minutes will be added to the surgical intervention time for the preplanning of the navigation the day before the operation on the Brainlab workstation.
次要结局
- Anaesthesia time (minutes)(at Operation day (V2, up to 24 hours))
- Operation time (minutes)(at Operation day (V2, up to 24 hours))
- Change in Evan's Index(before Operation day (V1) and 2-3 days post-op. (V3))
- rate of complications (infection, bleeding, complications associated with navigation method)(from Operation day (V2, up to 24 hours) until 6 months postop. (V6))
- Number of puncture attempts(at Operation day (V2, up to 24 hours))
- Catheter placement (optimal vs. not optimal)(at Operation day (V2,up to 24 hours), 2-3 days post-op. (V3), at discharge (V 4, approx. 7 days postop.), 6-8 weeks post-op (V5),6 months postop. (V6))
- mortality(from Operation day (V2, up to 24 hours) until 6 months postop. (V6))
- Change in volumetry of side ventricles(1 day before Operation day (V1, up to 24 hours) and 2-3 days post-op. (V3))
- revision surgery (yes/no)(from Operation day (V2,up to 24 hours) until 6 months postop. (V6))