The CSF Shunt Entry Site Trial

Status Active, not recruiting

Clinical Trial Summary

The purpose of the study is to compare the survival time (time to first shunt failure) of ventriculoperitoneal (VP) shunts inserted through an anterior entry site with those inserted through a posterior entry site in children. Shunt entry site is the location on the head that the shunt catheter enters the brain on its path to the fluid-filled spaces in the brain, the ventricles. Entry sites can be anterior or posterior.

Clinical Trial Description

The study is a multi-centered, randomized, controlled trial comparing two commonly used CSF shunt insertion techniques, anterior and posterior entry site. There is conflicting information and opinions in the pediatric hydrocephalus literature regarding entry site's effect on shunt survival. This trial is designed to detect a 10% or more difference in the rate of shunt survival at one year between the two techniques. The trial will be conducted by the Hydrocephalus Clinical Research Network and the Hydrocephalus Association. It is a four year study with an estimated sample size of 448 patients. Patients will be randomized in the operating room. Subjects will be followed for a minimum of 18 months. ;

Study Design

Related Conditions & MeSH terms

Hydrocephalus

Clinical Trial Details

NCT number	NCT02425761
Study type	Interventional
Source	Baylor College of Medicine
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	April 1, 2015
Completion date	December 31, 2020

View Details

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