Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

NCT04450797 | Completed

• 1 other identifier: 2019-02157; ch20Leu
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventriculoperitoneal Shunt (VPS); Hydrocephalus

Keywords

Ventriculoperitoneal shunt (VPS)-dependency; VPS placement; Stereotactic Navigated Ventriculoperitoneal Shunt Placement; Ultrasound Guided (US-G) Ventriculoperitoneal Shunt Placement

Outcome Measures

Primary Outcomes (1)

• surgical intervention time (minutes)

  time spent in the Operating Room (OR) by the surgeon, includes preparation time together (patient positioning, head clamping in the stereotactic navigation group) with the operation time of the neurosurgical part. Beginning ("positioning") and ending ("suture neurosurgical part") of this time interval is clearly defined and will be in a standardized manner recorded by blinded anaesthesiologists. . In the stereotactic navigation group, an additional 5 minutes will be added to the surgical intervention time for the preplanning of the navigation the day before the operation on the Brainlab workstation.

  at Operation day (V2, up to 24 hours)

Secondary Outcomes (9)

• Operation time (minutes)

  at Operation day (V2, up to 24 hours)

• Anaesthesia time (minutes)

  at Operation day (V2, up to 24 hours)

• Number of puncture attempts

  at Operation day (V2, up to 24 hours)

• Catheter placement (optimal vs. not optimal)

  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)

• Change in volumetry of side ventricles

  1 day before Operation day (V1, up to 24 hours) and 2-3 days post-op. (V3)

Study Arms (2)

US -G VPS placement

ACTIVE COMPARATOR

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

Stereotactic navigation for VPS placement

ACTIVE COMPARATOR

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

Interventions

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

US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz). Head not fixed, placed on horseshoe head holder, no preoperative navigation planning, catheter will be cut in length after positioning under real-time US guidance.

US -G VPS placement

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

Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1). Head fixed in head clamp, entry point, trajectory and catheter length planned based on preoperative computer tomography imaging, catheter placed using navigated stylet.

Stereotactic navigation for VPS placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Neurosurgery, University Hospital of Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34011396 DERIVED

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Severina Leu, Dr. med.

  Department of Neurosurgery, University Hospital of Basel

  PRINCIPAL INVESTIGATOR

• Luigi Mariani, Prof. Dr. med.

  Department of Neurosurgery, University Hospital of Basel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The primary outcome is the surgical intervention time, recorded by blinded anaesthesiologists. Some of the secondary outcomes (catheter placement (optimal vs. not optimal, grade I to IV), volumetry of side ventricles, Evans' Index) are measured by a blinded neuroradiologist.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 30, 2020
• Study Start: February 26, 2020
• Primary Completion: June 19, 2024
• Study Completion: January 6, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

CH (1)