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Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details

Ventriculoperitoneal Shunt (VPS), Hydrocephalus

NCT04450797

University Hospital, Basel, Switzerland

14 May 2024

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