Shunt failure remains a significant problem in pediatric patients with hydrocephalus. If reliable techniques for the accurate placement of ventricular catheters can be developed, shunt survival may improve. The purpose of this study is to assess the efficacy and safety of the ultrasound guided shunt insertion technique in the hands of experienced surgeons. The primary outcome measure is ventricular catheter location determined from post-operative brain images. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus. Pediatric neurosurgeons at HCRN centers enrolled in this study will perform either ultrasound guided shunt surgery or a conventional shunt surgery. Patients who undergo conventional shunt surgery will serve as a contemporary control group.
Study Type
OBSERVATIONAL
Enrollment
67
Children's Hospital of Alabama
Birmingham, Alabama, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Sick Children's Hospital
Toronto, Ontario, Canada
The primary endpoint for the study is ventricular catheter location (VCL) as assessed on the first post-operative scan (US, CT, or MRI brain).
Time frame: The first post-operative scan will only be used in the study if it occurs within 105 days of shunt insertion.
Shunt survival will be reported.
Time frame: Up to one year after the date of shunt placement.
Any complications, intraoperative and postoperative, will be reported.
Time frame: From the time of surgery until the time the subject is discharged from the hospital.
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