Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies
- Conditions
- Ventriculoperitoneal Shunt MalfunctionHydrocephalus
- Interventions
- Device: Non-programmable valveDevice: Programmable valve
- Registration Number
- NCT05534659
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.
- Detailed Description
Relatively high revision rates up to 32% of CSF shunting operations remained an unsolved problem for neurosurgeons. The cause of revisions were diverse, including overdrainage/underdrainage, shunting system obstruction, infection or technical skill related. Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.
The investigators reviewed the chart of all patients with hydrocephalus receiving index ventricular CSF shunt operations conducted at a single institution in northern Taiwan from January 2017 to December 2017. Patients included in the study were followed up for at least five years. Statistical tests including independent t-test, Chi-square test and Fisher's exact test were used for comparative analysis, and Kaplan-Meier curve using log-rank test was performed to compare the revision-free survival between the PV and NPV groups
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 325
- received shunting operations at Chang Gung Medical Foundation, Linkou Branch from 2017/01/01~2017/12/31
- Patients who received index ventricular CSF shunt at other hospitals,
- Patients who received index ventricular CSF shunt before January 1st 2017,
- Patients who were younger than 18
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-programmable valve(NPV) group Non-programmable valve Adult patients with hydrocephalus who received non-programmable ventricular CSF shunts operation. Programmable valve(PV) group Programmable valve Adult patients with hydrocephalus who received programmable ventricular CSF shunts operation.
- Primary Outcome Measures
Name Time Method Initial Shunt revision rate since the time of index operation until the initial revision or 2022/07/31 the ratio of the total number of patients with at least one revision to the total number of patients included in this study
Revision-free survival since the time of index operation until the initial revision or 2022/07/31 the interval between index operation and the initial revision
Total Shunt revision rate since the time of index operation until the initial revision or 2022/07/31 the ratio of the total number of revisions to the total number of ventricular CSF shunt operations
Type of the revision operation since the time of index operation until the initial revision or 2022/07/31 the detailed description of the revision operation
The cause of shunt revision since the time of index operation until the initial revision or 2022/07/31 the cause of the shunt malfunction warranting revision operation
- Secondary Outcome Measures
Name Time Method Shunt revision-free survival among different hydrocephalus etiologies since the time of index operation until the initial revision or 2022/07/31 the individual interval between index operation and the initial revision among different hydrocephalus etiologies