This study is a prospective observational registry study that enrolls all patients aged 60 years or older suspected of having idiopathic normal pressure hydrocephalus based on the Third Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. From the cohort registered, patients judged to be candidates for surgery based on the 3rd Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. These patients will be randomized 1:1 to undergo either ventriculoperitoneal shunt surgery under general anesthesia or lumbar peritoneal shunt surgery under local anesthesia. A randomized clinical trial would attest the non-inferiority of lumbar peritoneal shunt surgery under local anesthesia compared to ventriculoperitoneal shunt surgery under general anesthesia regarding the improvement in timed up-and-go test scores at 3 months post-surgery relative to pre-surgery levels.
Probable iNPH patients
Age 60 years or older at the time of the tap test
Patients capable of performing the Timed Up and Go test
Patients assignable within 2 weeks (14 days) of obtaining RCT consent
Patients deemed unsuitable for lumbar-abdominal shunt surgery due to advanced degeneration of the lumbar spine and spinal canal, etc.
Patients deemed unsuitable for abdominal shunt surgery due to a history of multiple open abdominal surgeries, a history of severe intra-abdominal infection, etc.
Other patients deemed unsuitable by the attending physician
Parallel
ventriculoperitoneal shunt surgery under general anesthesia
Procedure/Surgeryventriculoperitoneal shunt procedure was performed via right posterior horn puncture under general anesthesia
lumbar-peritoneal shunt procedure under local anesthesia
Procedure/SurgeryPentazocine and midazolam are administered intravenously to induce conscious sedation, and a lumbar-peritoneal shunt procedure is performed using local infiltration anesthesia with 1% lidocaine.
Change in timed up and go test score
Intensive Care Delirium Screening Checklist score
0-8 scale (0 best and 8 worst)
10% or greater improvement in the timed up and go score
Change in timed up and go score
Change in timed up and go score
All-cause deaths
All-cause deaths
Development of chronic subdural hematoma (hematoma thickness ≥10 mm)
Surgery for subdural hematoma
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Institute for Clinical Effectiveness, Japan
Lead sponsor
Nadogaya Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
