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

Comparison of Benefit and Survival for Different Etiologies of Adult Patients With Hydrocephalus Between Programmable Cerebrospinal Fluid Ventricular Shunt and Non-programmable Cerebrospinal Fluid Ventricular Shunt

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05534659
Enrollment
325
Registered
2022-09-09
Start date
2017-01-01
Completion date
2022-07-31
Last updated
2022-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus, Ventriculoperitoneal Shunt Malfunction

Keywords

Hydrocephalus, Programmable shunt, Long-term outcome

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

Interventions

DEVICEProgrammable valve

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

DEVICENon-programmable valve

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

Sponsors

Ministry of Science and Technology, Taiwan
CollaboratorOTHER_GOV
Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Initial Shunt revision ratesince the time of index operation until the initial revision or 2022/07/31the ratio of the total number of patients with at least one revision to the total number of patients included in this study
Total Shunt revision ratesince the time of index operation until the initial revision or 2022/07/31the ratio of the total number of revisions to the total number of ventricular CSF shunt operations
The cause of shunt revisionsince the time of index operation until the initial revision or 2022/07/31the cause of the shunt malfunction warranting revision operation
Type of the revision operationsince the time of index operation until the initial revision or 2022/07/31the detailed description of the revision operation
Revision-free survivalsince the time of index operation until the initial revision or 2022/07/31the interval between index operation and the initial revision

Secondary

MeasureTime frameDescription
Shunt revision-free survival among different hydrocephalus etiologiessince the time of index operation until the initial revision or 2022/07/31the individual interval between index operation and the initial revision among different hydrocephalus etiologies

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026