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

Chang Gung Medical Foundation

Status: Completed

Conditions: Hydrocephalus; Ventriculoperitoneal Shunt Malfunction

Treatments: Device: Programmable valve; Device: Non-programmable valve

Study type: Observational

Funder types: Other

Identifiers

NCT05534659

202200775B0

Details and patient eligibility

About

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.

Full 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

Enrollment: 325 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

325 participants in 2 patient groups

Programmable valve(PV) group

Description:

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

Treatment:

Device: Programmable valve

Non-programmable valve(NPV) group

Description:

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

Treatment:

Device: Non-programmable valve