Intraoperative Ultrasound Guided compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement: Study Protocol for a Randomized Controlled Study

BACKGROUND 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. 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. METHODS In 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. DISCUSSION To 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 REGISTRATION Business 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.