Clinical trial NCT04450797: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventriculoperitoneal Shunt (VPS)
Hydrocephalus
Keywords: Ventriculoperitoneal shunt (VPS)-dependency
VPS placement
Stereotactic Navigated Ventriculoperitoneal Shunt Placement
Ultrasound Guided (US-G) Ventriculoperitoneal Shunt Placement
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: surgical intervention time (minutes)
timeFrame: at Operation day (V2, up to 24 hours)
Secondary outcomes:
measure: Operation time (minutes)
timeFrame: at Operation day (V2, up to 24 hours)
measure: Anaesthesia time (minutes)
timeFrame: at Operation day (V2, up to 24 hours)
measure: Number of puncture attempts
timeFrame: at Operation day (V2, up to 24 hours)
measure: Catheter placement (optimal vs. not optimal)
timeFrame: at Operation day (V2,up to 24 hours), 2-3 days post-op. (V3), at discharge (V 4, approx. 7 days postop.), 6-8 weeks post-op (V5),6 months postop. (V6)
measure: Change in volumetry of side ventricles
timeFrame: 1 day before Operation day (V1, up to 24 hours) and 2-3 days post-op. (V3)
measure: Change in Evan's Index
timeFrame: before Operation day (V1) and 2-3 days post-op. (V3)
measure: rate of complications (infection, bleeding, complications associated with navigation method)
timeFrame: from Operation day (V2, up to 24 hours) until 6 months postop. (V6)
measure: mortality
timeFrame: from Operation day (V2, up to 24 hours) until 6 months postop. (V6)
measure: revision surgery (yes/no)
timeFrame: from Operation day (V2,up to 24 hours) until 6 months postop. (V6)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Neurosurgery, University Hospital of Basel
Study officials:
affiliation: Department of Neurosurgery, University Hospital of Basel
name: Severina Leu, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurosurgery, University Hospital of Basel
name: Luigi Mariani, Prof. Dr. med.
role: STUDY_DIRECTOR
References:
citation: Leu S, Halbeisen F, Mariani L, Soleman J. Intraoperative ultrasound-guided compared to stereotactic navigated ventriculoperitoneal shunt placement: study protocol for a randomised controlled study. Trials. 2021 May 19;22(1):350. doi: 10.1186/s13063-021-05306-5.