Anterior versus posterior entry site for ventriculoperitoneal shunt insertion: a randomized controlled trial by the Hydrocephalus Clinical Research Network.
Autor: | Whitehead WE; 1Department of Neurosurgery, Baylor College of Medicine, Houston, Texas., Riva-Cambrin J; 2Department of Neurosurgery, University of Calgary, Calgary, Alberta, Canada., Wellons JC; 3Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee., Kulkarni AV; 4Department of Neurosurgery, University of Toronto, Toronto, Ontario, Canada., Limbrick DD; 5Department of Neurosurgery, Washington University, St. Louis, Missouri., Wall VL; 6Department of Pediatrics, University of Utah, Salt Lake City, Utah., Rozzelle CJ; 7Department of Neurosurgery, University of Alabama, Birmingham, Alabama., Hankinson TC; 8Department of Neurosurgery, University of Colorado, Aurora, Colorado., McDonald PJ; 9Department of Neurosurgery, University of British Columbia, Vancouver, British Columbia, Canada., Krieger MD; 10Department of Neurosurgery, University of Southern California, Los Angeles, California., Pollack IF; 11Department of Neurosurgery, University of Pittsburgh, Pittsburgh, Pennsylvania., Tamber MS; 9Department of Neurosurgery, University of British Columbia, Vancouver, British Columbia, Canada., Pindrik J; 12Department of Neurosurgery, Ohio State University, Columbus, Ohio., Hauptman JS; 13Department of Neurosurgery, University of Washington, Seattle, Washington., Naftel RP; 3Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee., Shannon CN; 3Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee., Chu J; 10Department of Neurosurgery, University of Southern California, Los Angeles, California., Jackson EM; 14Department of Neurosurgery, Johns Hopkins University, Baltimore, Maryland., Browd SR; 13Department of Neurosurgery, University of Washington, Seattle, Washington., Simon TD; 15Department of Pediatrics, Keck School of Medicine at the University of Southern California, Los Angeles, California., Holubkov R; 6Department of Pediatrics, University of Utah, Salt Lake City, Utah., Reeder RW; 6Department of Pediatrics, University of Utah, Salt Lake City, Utah., Jensen H; 6Department of Pediatrics, University of Utah, Salt Lake City, Utah., Koschnitzky JE; 16Hydrocephalus Association, Washington, DC; and., Gross P; 16Hydrocephalus Association, Washington, DC; and., Drake JM; 4Department of Neurosurgery, University of Toronto, Toronto, Ontario, Canada., Kestle JRW; 17Department of Neurosurgery, University of Utah, Salt Lake City, Utah. |
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Jazyk: | angličtina |
Zdroj: | Journal of neurosurgery. Pediatrics [J Neurosurg Pediatr] 2021 Nov 19; Vol. 29 (3), pp. 257-267. Date of Electronic Publication: 2021 Nov 19 (Print Publication: 2022). |
DOI: | 10.3171/2021.9.PEDS21391 |
Abstrakt: | Objective: The primary objective of this trial was to determine if shunt entry site affects the risk of shunt failure. Methods: The authors performed a parallel-design randomized controlled trial with an equal allocation of patients who received shunt placement via the anterior entry site and patients who received shunt placement via the posterior entry site. All patients were children with symptoms or signs of hydrocephalus and ventriculomegaly. Patients were ineligible if they had a prior history of shunt insertion. Patients received a ventriculoperitoneal shunt after randomization; randomization was stratified by surgeon. The primary outcome was shunt failure. The planned minimum follow-up was 18 months. The trial was designed to achieve high power to detect a 10% or greater absolute difference in the shunt failure rate at 1 year. An independent, blinded adjudication committee determined eligibility and the primary outcome. The study was conducted by the Hydrocephalus Clinical Research Network. Results: The study randomized 467 pediatric patients at 14 tertiary care pediatric hospitals in North America from April 2015 to January 2019. The adjudication committee, blinded to intervention, excluded 7 patients in each group for not meeting the study inclusion criteria. For the primary analysis, there were 229 patients in the posterior group and 224 patients in the anterior group. The median patient age was 1.3 months, and the most common etiologies of hydrocephalus were postintraventricular hemorrhage secondary to prematurity (32.7%), myelomeningocele (16.8%), and aqueductal stenosis (10.8%). There was no significant difference in the time to shunt failure between the entry sites (log-rank test, stratified by age < 6 months and ≥ 6 months; p = 0.061). The hazard ratio (HR) of a posterior shunt relative to an anterior shunt was calculated using a univariable Cox regression model and was nonsignificant (HR 1.35, 95% CI, 0.98-1.85; p = 0.062). No significant difference was found between entry sites for the surgery duration, number of ventricular catheter passes, ventricular catheter location, and hospital length of stay. There were no significant differences between entry sites for intraoperative complications, postoperative CSF leaks, pseudomeningoceles, shunt infections, skull fractures, postoperative seizures, new-onset epilepsy, or intracranial hemorrhages. Conclusions: This randomized controlled trial comparing the anterior and posterior shunt entry sites has demonstrated no significant difference in the time to shunt failure. Anterior and posterior entry site surgeries were found to have similar outcomes and similar complication rates. |
Databáze: | MEDLINE |
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