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Safety evaluation of intraspinal injection of cleaning perfusate for cerebrospinal surgery on the diagnosis of cerebrospinal fluid(CSF)-leakage in CSF hypovolemia

Safety evaluation of intraspinal injection of cleaning perfusate for cerebrospinal surgery on the diagnosis of cerebrospinal fluid(CSF)-leakage in CSF hypovolemia - SICCS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022549
Enrollment
5
Registered
2016-06-01
Start date
2016-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebrospinal fluid hypovolemia

Interventions

Cases were diagnosed with cerebrospinal fluid hypovolemia in accordance with cerebrospinal fluid leakage syndrome image judgment criteria and image diagnostic criteria. After conducting the presented

Sponsors

Department of Neurosurgery, Kochi Medical School, Kochi University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients 18 years or older for whom cerebrospinal fluid pressure was 60mmH2O or less.

Exclusion criteria

Exclusion criteria: Patients with difficulty communicating, patients with a bleeding tendency, patients allergic to contrast agents or RI, patients for whom lumbar puncture is difficult, pregnant women,patients who have been determined ineligible by the evaluator.

Design outcomes

Primary

MeasureTime frame
The presence or absence of adverse events, the type, the severity, the safety integrity, incidence frequency, and incidence duration were assessed. Duration for which information on the presence or absence of adverse events was collected: From the start of disinfection for the examination to the follow-up one week after discharge from the hospital. (The permissible range was - 3 days + 7 days)

Secondary

MeasureTime frame
Leakage point (a comparison of the conventional examination method and the new examination method from this study was conducted) VAS score at the time consent was obtained, at the time of discharge from the hospital, at the follow-up one week after discharge from the hospital, and at the follow-up three months after discharge from the hospital (The permissible range was -+ 1 month) VAS score was obtained the maximum of pain in less than one week from the evaluation.VAS score at discharge are excluded.

Countries

Japan

Contacts

Public ContactEiichi Nakai

Kochi Medical School, Kochi University Department of Neurosurgery

enakai@kochi-u.ac.jp+810888802397

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026