Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hydrocephalus Ventriculoperitoneal Shunt Malfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Programmable valve(PV) group

Adult patients with hydrocephalus who received programmable ventricular CSF shunts operation.

Programmable valve

Intervention Type DEVICE

Programmable valve used in the study included Medtronic Strata, B-Braun ProGav, Codman Certas.

Non-programmable valve(NPV) group

Adult patients with hydrocephalus who received non-programmable ventricular CSF shunts operation.

Non-programmable valve

Intervention Type DEVICE

Non-programmable valve used in the study was Medtronic CSF-flow control valve.

Interventions

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Programmable valve

Programmable valve used in the study included Medtronic Strata, B-Braun ProGav, Codman Certas.

Intervention Type DEVICE

Non-programmable valve

Non-programmable valve used in the study was Medtronic CSF-flow control valve.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* received shunting operations at Chang Gung Medical Foundation, Linkou Branch from 2017/01/01\~2017/12/31

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No