Clinical trial NCT05534659: Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Ventriculoperitoneal Shunt Malfunction
Keywords: Hydrocephalus
Programmable shunt
Long-term outcome
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2022-09-09
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Initial Shunt revision rate
timeFrame: since the time of index operation until the initial revision or 2022/07/31
measure: Total Shunt revision rate
timeFrame: since the time of index operation until the initial revision or 2022/07/31
measure: The cause of shunt revision
timeFrame: since the time of index operation until the initial revision or 2022/07/31
measure: Type of the revision operation
timeFrame: since the time of index operation until the initial revision or 2022/07/31
measure: Revision-free survival
timeFrame: since the time of index operation until the initial revision or 2022/07/31
Secondary outcomes:
measure: Shunt revision-free survival among different hydrocephalus etiologies
timeFrame: since the time of index operation until the initial revision or 2022/07/31
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neurosurgery Chang Gung Memorial Hospital Chang Gung Medical College and University
name: ZHUO HAO Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.