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Completed

NCT Number: NCT05534659

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

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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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases Ventriculoperitoneal Shunt Malfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Programmable valve

Device

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

Non-programmable valve

Device

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

Primary outcomes

  1. Initial Shunt revision rate

    Time frame: 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

  2. Total Shunt revision rate

    Time frame: 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

  3. The cause of shunt revision

    Time frame: since the time of index operation until the initial revision or 2022/07/31

    the cause of the shunt malfunction warranting revision operation

  4. Type of the revision operation

    Time frame: since the time of index operation until the initial revision or 2022/07/31

    the detailed description of the revision operation

  5. Revision-free survival

    Time frame: since the time of index operation until the initial revision or 2022/07/31

    the interval between index operation and the initial revision

Secondary outcomes

  1. Shunt revision-free survival among different hydrocephalus etiologies

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2022
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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