Neurological disorders
Conditions
Interventions
Experimental group:Dura mater medical adhesive
Control group:Standard treatment methods (clinical routine skull base reconstruction approach, but without the use of sealants, such as absorbable dura mater sealing medical adhesives, DuraSeal, and p
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age >=18 years old, gender not limited. 2) Patients who are scheduled to undergo endoscopic skull base surgery but experience moderate to high flow cerebrospinal fluid leakage during the operation and require skull base reconstruction. 3) The patient and/or the guardian agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with uncontrolled acute infection. 2) Patients with a history of failed skull base reconstruction and persistent CSF leak. 3) Patients with a history of radiotherapy in the operative area. 4) Life expectancy < 3 months. 5) Pregnant or lactating women. 6) Patients with positive HIV antibody screening. 7) Patients with severe liver dysfunction who cannot tolerate the surgery. 8) Patients with uncontrolled severe mental illness, which in the investigator's judgment may affect the subject's compliance or safety. 9) Patients judged by the investigator to have poor compliance and unable to complete the study as required. 10) Patients unable to understand the investigator's introduction or explanation of the study. 11) Other conditions considered by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of absence of cerebrospinal fluid leak within 1 month postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| No cerebrospinal fluid leakage rate within 3 months after the operation; | — |
Countries
China
Contacts
Public ContactGui Songbai
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed