Evidence map›Paper›PMID 34011396›Full record

ArticleTrials2021

Intraoperative ultrasound-guided compared to stereotactic navigated ventriculoperitoneal shunt placement: study protocol for a randomised controlled study.

Severina Leu, Florian Halbeisen, Luigi Mariani, Jehuda Soleman

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04450797 (Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04450797 nacompletednot on this map

Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement: A Randomized Controlled Study

TypeinterventionalSponsorUniversity Hospital, Basel, SwitzerlandRan2020 to 2025Enrolled136ConditionsVentriculoperitoneal Shunt (VPS), HydrocephalusArmsUS -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz)., Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Severina LeuDepartment of Neurosurgery, University Hospital of Basel, Spitalstrasse 21, 4031, Basel, Switzerland. severina.leu@unibas.ch.ORCID http://orcid.org/0000-0002-2963-2891
Florian HalbeisenBasel Institute for Clinical Epidemiology & Biostatistics, University Hospital of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
Luigi MarianiDepartment of Neurosurgery, University Hospital of Basel, Spitalstrasse 21, 4031, Basel, Switzerland.
Jehuda SolemanDepartment of Neurosurgery, University Hospital of Basel, Spitalstrasse 21, 4031, Basel, Switzerland.
University Hospital of Basel · CHUniversity of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVentriculoperitoneal shunt (VPS) placement is one of the most frequent neurosurgical procedures and the operation is performed in a highly standardised manner under maintenance of highest infection precautions. Short operation times are important since longer duration of surgery can increase the risk for VPS complications, especially infections. The position of the proximal ventricular catheter influences shunt functioning and survival. With freehand placement, rates of malpositioned VPS are still high. Several navigation techniques for improvement of shunt placement have been developed. Studies comparing these techniques are sparse. The aim of this study is to prospectively compare ultrasound (US) guided to stereotactic navigated shunt placement using optical tracking with the focus on operation time and efficiency.

methodsIn this prospective randomised, single-centre, partially-blinded study, we will include all patients undergoing VPS placement in our clinic. The patients will be randomised into two groups, one group undergoing US-guided (US-G) and the other group stereotactic navigated VPS placement using optical tracking. The primary outcome will be the surgical intervention time. This time span consists of the surgical preparation time together with the operation time and is given in minutes. Secondary outcomes will be accuracy of catheter positioning, VPS dysfunction and need for revision surgery, total operation and anaesthesia times, and amount of intraoperative ventricular puncture attempts as well as complications, any morbidity and mortality. DISCUSSION: To date, there is no prospective data available comparing these two navigation techniques. A randomised controlled study is urgently needed in order to provide class I evidence for the best possible surgical technique of this frequent surgery.

trial registrationBusiness Administration System for Ethical Committees (BASEC) 2019-02157, registered on 21 November 2019, https://www.kofam.ch/de/studienportal/suche/88135/studie/49552 ; clinicalTrials.gov: NCT04450797 , registered on 30 June 2020.

Indexed as

HydrocephalusVentriculoperitoneal ShuntCathetersHumansProspective StudiesRandomized Controlled Trials as TopicRetrospective StudiesUltrasonography, InterventionalHydrocephalusRandomised controlled trialStereotaxic techniquesSurgical techniqueUltrasoundVentriculoperitoneal shunt

Identifiers

PMID34011396
PMCPMC8132376
OpenAlexW3135841274

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.