Prospective Shunt Complication Study

Suspended

• Conditions: Shunt; Complications, Ventricular (Communicating)

• Registration Number: NCT02778997
• Lead Sponsor: University of Zurich

Brief Summary

Complications in patients with cerebrospinal fluid (CSF) shunts are common. Thus, these patients are frequently admitted for suspicion of a shunt dysfunction (SD). However, the symptoms of a SD are often unspecific and the required diagnostics are time consuming, expensive, invasive and may involve radiation exposure. In a prospective observational study it is planned to find out, how often a suspected shunt dysfunction is found, which kinds of shunt dysfunction are seen and if there is a correlation between the shunt dysfunctions and the age of the shunt. Furthermore, it is intended to find out, if there are symptom-patterns specific for certain shunt dysfunctions.

Detailed Description

All patients who are admitted for suspected shunt-dysfunction will be included. Patient data, detailed data about the shunt, patient's symptoms and all findings will be recorded in the CRF. After 4-8 weeks all patients will be followed-up to add missing data and correct initial findings with the benefit of a retrospective view. After 2 years, data will be analyzed.

Study Timeline

• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-20
• Study Start: 2017-04-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age >= 18
• State after implantation of a CSF shunt

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Exclusion Criteria

• refusion participation in the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alternate Diagnosis (multiple diagnoses possible)	4-8 weeks after first presentation	If the suspected diagnosis of a shunt dysfunction is not approved, the alternate diagnosis leading to the patient's symptoms is recorded. Every possible medical disorder might lead to presentation of the patient. Thus, no catalogue of possible diagnoses is given.
Kind of Shunt Dysfunction (infection/disruption/kinking/obstruction/others)	4-8 weeks after first presentation	In case of a confirmed shunt dysfunction, the kind of dysfunction is recorded
Time Span after Shunt Implantation (months)	4-8 weeks after first presentation	Certain kinds of shunt dysfunctions seem to appear at a certain "age" of a shunt. The time after implantation/last revision of the shunt is recorded. The age of the shunt / time span after first implantation is measured in months.
Confirmation of Shunt Dysfunction (yes/no)	4-8 weeks after first presentation	The correctness of the suspected diagnosis of a shunt dysfunction

Trial Locations

Locations (2)

Dept. of Neurosurgery, Zurich University Hospital; 🇨🇭 Zurich, Switzerland

Zurich University Hospital; 🇨🇭 Zurich, Switzerland