Abstract
BackgroundVentriculoperitoneal shunt (VPS) placement is one of the most frequent neurosurgical procedures and the operation is performed in a highly standardised manner under maintenance of highest infection precautions. Short operation times are important since longer duration of surgery can increase the risk for VPS complications, especially infections. The position of the proximal ventricular catheter influences shunt functioning and survival. With freehand placement, rates of malpositioned VPS are still high. Several navigation techniques for improvement of shunt placement have been developed. Studies comparing these techniques are sparse. The aim of this study is to prospectively compare ultrasound (US) guided to stereotactic navigated shunt placement using optical tracking with the focus on operation time and efficiency.MethodsIn this prospective randomised, single-centre, partially-blinded study, we will include all patients undergoing VPS placement in our clinic. The patients will be randomised into two groups, one group undergoing US-guided (US-G) and the other group stereotactic navigated VPS placement using optical tracking. The primary outcome will be the surgical intervention time. This time span consists of the surgical preparation time together with the operation time and is given in minutes. Secondary outcomes will be accuracy of catheter positioning, VPS dysfunction and need for revision surgery, total operation and anaesthesia times, and amount of intraoperative ventricular puncture attempts as well as complications, any morbidity and mortality.DiscussionTo date, there is no prospective data available comparing these two navigation techniques. A randomised controlled study is urgently needed in order to provide class I evidence for the best possible surgical technique of this frequent surgery.Trial registrationBusiness Administration System for Ethical Committees (BASEC) 2019-02157, registered on 21 November 2019, https://www.kofam.ch/de/studienportal/suche/88135/studie/49552; clinicalTrials.gov: NCT04450797, registered on 30 June 2020.
Highlights
Background and rationale {6a} Ventriculoperitoneal shunt (VPS) placement is one of the most frequent procedures in neurosurgical practice
VPS placement using optical stereotactic navigation has shown a high accuracy in catheter positioning, while the main limitations are that for referencing, the head of the patient needs to be fixed in a head holder and pins and the preoperative set-up can be time-consuming [7], leading to longer operation times
Interventions Explanation for the choice of comparators {6b} The main aim of this study is to focus on the safety and feasibility of US-G VPS placement, with a special interest lying on the surgical intervention time
Summary
Background and rationale {6a} Ventriculoperitoneal shunt (VPS) placement is one of the most frequent procedures in neurosurgical practice. The indications vary from normal pressure hydrocephalus in elderly patients to VPS dependency after subarachnoid haemorrhage, infection or trauma, mostly in younger patients [1,2,3] This operation is done in a highly standardised manner with many steps taking place in an exactly defined order while maintaining highest infection precautions. VPS placement using optical stereotactic navigation has shown a high accuracy in catheter positioning, while the main limitations are that for referencing, the head of the patient needs to be fixed in a head holder and pins and the preoperative set-up can be time-consuming [7], leading to longer operation times. Ventriculoperitoneal shunt (VPS) placement is one of the most frequent neurosurgical procedures and the operation is performed in a highly standardised manner under maintenance of highest infection precautions. The aim of this study is to prospectively compare ultrasound (US) guided to stereotactic navigated shunt placement using optical tracking with the focus on operation time and efficiency
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