Brief Title
Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement
Official Title
Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement: A Randomized Controlled Study
Brief Summary
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.
Detailed 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.
Study Type
Interventional
Primary Outcome
surgical intervention time (minutes)
Secondary Outcome
Operation time (minutes)
Condition
Ventriculoperitoneal Shunt (VPS)
Intervention
US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).
Study Arms / Comparison Groups
US -G VPS placement
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
130
Start Date
February 26, 2020
Completion Date
August 2022
Primary Completion Date
August 2022
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Severina Leu, Dr. med., 0041 76 537 84 28, [email protected]
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT04450797
Organization ID
2019-02157; ch20Leu
Responsible Party
Sponsor
Study Sponsor
University Hospital, Basel, Switzerland
Study Sponsor
Severina Leu, Dr. med., Principal Investigator, Department of Neurosurgery, University Hospital of Basel
Verification Date
November 2021