ShuCS: Prospective Shunt Complication Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- Confirmation of Shunt Dysfunction (yes/no) [4-8 weeks after first presentation]
The correctness of the suspected diagnosis of a shunt dysfunction
- 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
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age >= 18
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State after implantation of a CSF shunt
Exclusion Criteria:
- refusion participation in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept. of Neurosurgery, Zurich University Hospital | Zurich | Switzerland | 8091 | |
| 2 | Zurich University Hospital | Zurich | Switzerland |
Sponsors and Collaborators
- University of Zurich
Investigators
- Study Director: Luca Regli, MD, Zurich University Hospital, Dept. of Neurosurgery
- Principal Investigator: Lennart H Stieglitz, MD, Zurich University Hospital, Dept. of Neurosurgery
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016-00174