The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH) have a better long-term outcome at 5 years when they are treated with a new procedure, endoscopic third ventriculostomy (ETV), than infants treated with the more traditional treatment, insertion of a cerebrospinal fluid (CSF) shunt.
TVH is a relatively uncommon condition in infants, in which CSF accumulates in the brain's ventricles due to a blockage in outflow at the level of cerebral aqueduct. This can cause increased intracranial pressure, with adverse effect on brain development. The causes of this include congenital aqueductal stensois or acquired aqueductal stenosis from previous brain hemorrhage or infection. TVH is currently treated through one of the following two approaches: * Extra-cranial CSF diversion through ventricular shunts. Extra-cranial shunting has been the standard approach over the past few decades, since functional shunts were first developed and inserted successfully. * Intra-cranial internal CSF diversion using endoscopic techniques. The principles of internal diversion were clear from the time neurosurgeons first understood the nature of hydrocephalus. However, internal diversion was never really practical or successful on a large scale until the more recent development of neuroendoscopy. There is currently a revived interest in diversionary hydrocephalus treatment through neuroendoscopic surgical techniques, with the primary focus on endoscopic third ventriculostomy (ETV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
A standard frontal burr hole will be made and an endoscopic camera used to visualize the floor of the third ventricle. A ventriculostomy will be created in the floor of the third using the surgeon's own preferred method of perforation.
The procedure involves creating a burr hole in the frontal or occipital regions and cannulating the ventricle with a silastic catheter. This is then attached to a valve mechanism and distal silastic tubing which runs subcutaneously in the peritoneal cavity.
Children's Medical Center of Dallas
Dallas, Texas, United States
Nacional de Pediatria
Buenos Aires, Argentina
Health Status Outcome as measured by the Health Utilities Index - 2
Time frame: At 5 years of age
Death
Time frame: Duration of the Study
Neurodevelopment as measured by the Denver Developmental Screening Test
Time frame: Up to 3 years of Age
Health status outcome using the Hydrocephalus Outcome Questionnaire
Time frame: At 5 years of Age
In-depth Evaluation of Neurodevelopment, Functioning and Intelligence, as mesured by the Weschler Intelligence Scale for Children or Weschler Preschool and Primary Scale of Intelligence
Time frame: At 5 years of Age
Number of Subsequent Hydrocephalus-Related Operations
Time frame: Duration of the Study
Surgical Morbidity
Time frame: Duration of the Study
Incidence of failure of initial intervention
Time frame: Duration of the Study
Hospitalization Time
Time frame: 5 years post-operation
Need for repeat radiological scans
Time frame: Duration of the Study
Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication
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Biocor Instituto
Nova Lima, Brazil
UNIFESP
São Paulo, Brazil
The Hospital for Sick Children
Toronto, Ontario, Canada
University Hospital Gießen and Marburg
Giessen, Germany
University of Debrecen
Debrecen, Hungary
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, India
All India Institute of Medical Sciences
New Delhi, India
Dana Children's Hospital, Tel Aviv Medical Center
Tel Aviv, Israel
...and 12 more locations
Time frame: Duration of the Study
Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation
Time frame: 3 years of age