Prospective Shunt Complication Study

Shunt; Complications, Ventricular (Communicating) Clinical Trial

— ShuCS  

Official title:

Prospective Shunt Complication Study (Pro-ShuCS)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02778997
• Other study ID #: 2016-00174
• Status: Suspended
• Start date: April 1, 2017
• Est. completion date: July 1, 2024

Study information

• Verified date: December 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 150
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• refusion participation in the study

Related Conditions & MeSH terms

• Shunt; Complications, Ventricular (Communicating)

Intervention

Procedure:
• CSF Shunt treatment for hydrocephalus
State after CSF shunt implantation

Locations

Country	Name	City	State
Switzerland	Dept. of Neurosurgery, Zurich University Hospital	Zurich
Switzerland	Zurich University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmation of Shunt Dysfunction (yes/no)	The correctness of the suspected diagnosis of a shunt dysfunction	4-8 weeks after first presentation
Primary	Kind of Shunt Dysfunction (infection/disruption/kinking/obstruction/others)	In case of a confirmed shunt dysfunction, the kind of dysfunction is recorded	4-8 weeks after first presentation
Primary	Alternate Diagnosis (multiple diagnoses possible)	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.	4-8 weeks after first presentation
Primary	Time Span after Shunt Implantation (months)	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.	4-8 weeks after first presentation