Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement (NaVPS)

University Hospital Basel

Status

Completed

Conditions

Hydrocephalus

Ventriculoperitoneal Shunt (VPS)

Treatments

Device: Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).

Device: US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).

Study type

Interventional

Funder types

Other

Identifiers

NCT04450797

2019-02157 ch20Leu;

Details and patient eligibility

About

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.

Full description

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.

Enrollment

136 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed Consent as documented by signature
Patients undergoing elective or emergent VPS placement (frontal or occipital shunt )

Exclusion criteria

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