Anterior versus posterior entry site for ventriculoperitoneal shunt insertion: a randomized controlled trial by the Hydrocephalus Clinical Research Network
- There was no significant difference in the time to shunt failure between the anterior or posterior shunt entry sites (log-rank test, p = 0.061)
- Rate of shunt-related complication was not significantly different between entry sites.
- Previous studies on the relationship between entry site and shunt survival produced conflicting results.
- This is a parallel-design randomized controlled trial to determine if the shunt entry site affects the risk of shunt failure. The primary outcome was shunt failure as defined as obstruction, overdrainage, loculation, or infection. Secondary objectives were surgical parameters (i.e. surgery duration, length of stay, catheter position) and complications (i.e. CSF leak, infection and new onset epilepsy)
- 467 patients (<18 years old) were randomized, 229 in posterior and 224 in anterior group. Surgeries were performed by 65 surgeons in 14 pediatric hospitals in North America. Primary outcome was determined by adjudication committee, blinded to intervention.
- No significant difference in the time to shunt failure between the entry sites stratified by age < 6 months and ≥ 6 months.
- A lower than expected shunt failure rate may have contributed to under-power of the study, resulting in failure to detect a difference between treatment groups, if one exists.
- Secondary analysis based on unblinded observation of treating neurosurgeon show a survival benefit for anterior site (log-rank test, p = 0.02).
- Unplanned analysis using as-treated, rather than intention-to-treat approach, revealed a survival advantage for the anterior entry (log-rank test, p = 0.02).