Prospective Shunt Complication Study

NCT ID: NCT02778997

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2027-07-01

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.

Conditions

Shunt; Complications, Ventricular (Communicating)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

CSF Shunt treatment for hydrocephalus

State after CSF shunt implantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• refusion participation in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Regli, MD

Role: STUDY_DIRECTOR

Zurich University Hospital, Dept. of Neurosurgery

Lennart H Stieglitz, MD

Role: PRINCIPAL_INVESTIGATOR

Zurich University Hospital, Dept. of Neurosurgery

Locations

Dept. of Neurosurgery, Zurich University Hospital

Zurich, , Switzerland

Zurich University Hospital

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2016-00174

Identifier Type: -

Identifier Source: org_study_id