Comparison of ventriculoperitoneal shunt to lumboperitoneal shunt in the treatment of posthemorrhagic hydrocephalus: A prospective, monocentric, non-randomized controlled trial

BACKGROUND: Ventriculoperitoneal shunt (VPS) surgery remains the most widely accepted and used option method to treat post-hemorrhagic hydrocephalus (PHH) worldwide while lumboperitoneal shunt (LPS) serves as an effectively alternative treatment. However, the outcomes of VPS and LPS in the treatment of PHH have not been compared in a prospective trial. METHODS AND DESIGN: In this monocentric, assessor-blinded, non-randomized controlled trial, 75 eligible patients with PHH for each group will be recruited to compare the outcomes of VPS cohort with that of LPS cohort. Each participant is evaluated before surgery, at the time of discharge, 3, and 6 months after surgery by experienced and practiced assessors. The primary outcome is the rate of shunt failure 6 months after shunt surgery. The secondary measure of efficacy is National Institute of Health stroke scale, together along with Glasgow coma scale, modified Rankin Scale, and Evans index at the evaluation point. A favorable outcome is defined as shunt success with an improvement of more than 1 point in the National Institute of Health stroke scale. Complication events occurring within 6 months after surgery are investigated. A serious adverse events throughout the study are recorded regarding the safety of shunts. DISCUSSION: The results of this trial will provide evidence for the treatment options for patients with PHH.