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

Hydrocephalus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05534659
• Other study ID #: 202200775B0
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: July 31, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus
• Ventriculoperitoneal Shunt Malfunction

Intervention

Device:
• Programmable valve
Programmable valve used in the study included Medtronic Strata, B-Braun ProGav, Codman Certas.
• Non-programmable valve
Non-programmable valve used in the study was Medtronic CSF-flow control valve.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Science and Technology, Taiwan

References & 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. Review. — View 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. — View 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 7:1-9. doi: 10.3171/2019.3.JNS183077. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Shunt revision-free survival among different hydrocephalus etiologies	the individual interval between index operation and the initial revision among different hydrocephalus etiologies	since the time of index operation until the initial revision or 2022/07/31