NCT05534659

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
Last Updated

September 16, 2022

Status Verified

August 1, 2022

Enrollment Period

5.2 years

First QC Date

September 6, 2022

Last Update Submit

September 14, 2022

Conditions

HydrocephalusVentriculoperitoneal Shunt Malfunction

Keywords

HydrocephalusProgrammable shuntLong-term outcome

Outcome Measures

Primary Outcomes (5)

  • Initial Shunt revision rate

    the ratio of the total number of patients with at least one revision to the total number of patients included in this study

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

  • Total Shunt revision rate

    the ratio of the total number of revisions to the total number of ventricular CSF shunt operations

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

  • The cause of shunt revision

    the cause of the shunt malfunction warranting revision operation

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

  • Type of the revision operation

    the detailed description of the revision operation

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

  • Revision-free survival

    the interval between index operation and the initial revision

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

Secondary Outcomes (1)

  • Shunt revision-free survival among different hydrocephalus etiologies

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

Study Arms (2)

Programmable valve(PV) group

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

Device: Programmable valve

Non-programmable valve(NPV) group

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

Device: Non-programmable valve

Interventions

Programmable valveDEVICE

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

Programmable valve(PV) group
Non-programmable valveDEVICE

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

Non-programmable valve(NPV) group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients who received CSF ventricular shunting operations at Chang Gung Medical Foundation, Linkou Branch, a tertiary medical center in northern Taiwan, would be included in the study.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Li M, Wang H, Ouyang Y, Yin M, Yin X. Efficacy and safety of programmable shunt valves for hydrocephalus: A meta-analysis. Int J Surg. 2017 Aug;44:139-146. doi: 10.1016/j.ijsu.2017.06.078. Epub 2017 Jun 22.

    PMID: 28648796BACKGROUND

  • Rinaldo L, Bhargav AG, Nesvick CL, Lanzino G, Elder BD. Effect of fixed-setting versus programmable valve on incidence of shunt revision after ventricular shunting for idiopathic normal pressure hydrocephalus. J Neurosurg. 2019 Jun 7;133(2):564-572. doi: 10.3171/2019.3.JNS183077. Print 2020 Aug 1.

    PMID: 31174190BACKGROUND

  • Reddy GK, Bollam P, Shi R, Guthikonda B, Nanda A. Management of adult hydrocephalus with ventriculoperitoneal shunts: long-term single-institution experience. Neurosurgery. 2011 Oct;69(4):774-80; discussion 780-1. doi: 10.1227/NEU.0b013e31821ffa9e.

    PMID: 21508873BACKGROUND

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • ZHUO HAO Liu, PhD

    Department of Neurosurgery Chang Gung Memorial Hospital Chang Gung Medical College and University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 9, 2022

Study Start

January 1, 2017

Primary Completion

March 1, 2022

Study Completion

July 31, 2022

Last Updated

September 16, 2022

Record last verified: 2022-08