Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
448 participants
INTERVENTIONAL
2015-04-01
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Anterior Entry SIte
Anterior entry site is defined as shunt surgery with catheter entry into the brain from an opening near the coronal suture, on the top of the head and near the front. Specifically, anterior entry is defined as ventricular catheter entry less than 1 centimeter anterior to the coronal suture near the mid-pupillary line.
Subjects randomized to this arm will undergo ventriculoperitoneal shunt insertion surgery using an anterior entry site.
Ventriculoperitoneal shunt insertion surgery
The most common treatment for hydrocephalus is the placement of a ventriculoperitoneal shunt in the operating room. A shunt is a flexible tube placed into the ventricular system, fluid filled chambers, of the brain that diverts the flow of CSF into another region of the body, usually the abdomen, also known as the peritoneal cavity, where it can be absorbed.
Posterior Entry Site
Posterior entry site is defined as shunt surgery with catheter entry into the brain from an opening near the lambdoid suture, on the back of the head. Specifically, posterior entry is defined as ventricular catheter entry 4 to 7 centimeters above the external occipital protuberance (inion), near the mid-pupillary line.
Subjects randomized to this arm will undergo ventriculoperitoneal shunt insertion surgery using a posterior entry site.
Ventriculoperitoneal shunt insertion surgery
The most common treatment for hydrocephalus is the placement of a ventriculoperitoneal shunt in the operating room. A shunt is a flexible tube placed into the ventricular system, fluid filled chambers, of the brain that diverts the flow of CSF into another region of the body, usually the abdomen, also known as the peritoneal cavity, where it can be absorbed.
Interventions
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Ventriculoperitoneal shunt insertion surgery
The most common treatment for hydrocephalus is the placement of a ventriculoperitoneal shunt in the operating room. A shunt is a flexible tube placed into the ventricular system, fluid filled chambers, of the brain that diverts the flow of CSF into another region of the body, usually the abdomen, also known as the peritoneal cavity, where it can be absorbed.
Eligibility Criteria
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Inclusion Criteria
2. Clinical evidence of hydrocephalus that requires a simple ventriculoperitoneal shunt as determined by a pediatric neurosurgeon; AND
3. No prior history of shunt insertion (a history of an external ventricular drain, ventricular reservoir, subgaleal shunt, and or endoscopic third ventriculostomy with or without choroid plexus coagulation is permissible); AND
4. Ventriculomegaly on imaging.
Exclusion Criteria
2. Active CSF or abdominal infection;
3. CSF leak without hydrocephalus;
4. Pseudotumor cerebri;
5. Hydranencephaly;
6. Loculations within the ventricular system (e.g. large intraventricular cysts or ventricular adhesions which create compartments that distort the ventricular anatomy; isolated trapped lateral ventricle). A small cyst within the ventricle does not meet these criteria;
7. Other difficulties that would preclude follow up at one year (e.g. terminal illness with life expectancy less than 18 months; family plans to move out of region or country);
8. A bilateral scalp, bone, or ventricular lesion that makes placement of either an anterior or a posterior shunt impracticable (e.g. cutis aplasia);
9. Bilateral slit like frontal horns or trigones defined as the widest distance between the medial and lateral walls less than 3 millimeters.
10. Patient is scheduled to have an intra-ventricular procedure (e.g. ETV, endoscopic biopsy, arachnoid cyst fenestration, fenestration of septum pellucidum) in addition to possible or definite VP shunt.
1 Day
17 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Alabama at Birmingham
OTHER
University of British Columbia
OTHER
University of Pittsburgh
OTHER
University of Toronto
OTHER
University of Utah
OTHER
University of Washington
OTHER
Vanderbilt University
OTHER
Washington University School of Medicine
OTHER
Hydrocephalus Association
OTHER
Ohio State University
OTHER
Johns Hopkins University
OTHER
University of Calgary
OTHER
University of Colorado, Denver
OTHER
University of Southern California
OTHER
Baylor College of Medicine
OTHER
Responsible Party
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William Whitehead
Professor
Principal Investigators
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William E Whitehead, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
John Kestle, MD
Role: STUDY_CHAIR
University of Utah
Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Children's Hospital Colorado
Denver, Colorado, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Related Links
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Hydrocephalus Clinical Research Network Website
Hydrocephalus Association Website
Other Identifiers
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H-35639
Identifier Type: -
Identifier Source: org_study_id