Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-26

Study Completion Date

2025-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Keyhole Surgery for the Positioning of the Distal Catheter in Ventricular Peritoneal Shunt Placement

NCT01739179

Ventricular Peritoneal Shunt Shunt Complications Shunt Failure +1 more

COMPLETED

A Study Comparing Shunt Placement Versus Endoscopic Third Ventriculostomy in the Treatment of Hydrocephalus

NCT01115270

Hydrocephalus, Normal Pressure

COMPLETED

The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique

NCT01007786

Pediatric Hydrocephalus

COMPLETED

Insertion of Frontal Ventricular Catheter of VP Shunt in Congenital Hydrocephalus Guided by Trans Fontanelle Ultrasound

NCT06664372

Ventriculoperitoneal Shunt Trans Fontanelle US Congenital Hydrocephalus

NOT_YET_RECRUITING NA

Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus

NCT03245138

Normal Pressure Hydrocephalus

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventriculoperitoneal Shunt (VPS) Hydrocephalus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

US -G VPS placement

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Stereotactic navigation for VPS placement

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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.

Intervention Type DEVICE

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

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No