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Clinical research on the high-flow cerebrospinal fluid leakage skull base reconstruction strategy of expanded endoscopic endonasal approach

Clinical research on the high-flow cerebrospinal fluid leakage skull base reconstruction strategy of expanded endoscopic endonasal approach

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105717
Enrollment
Unknown
Registered
2025-07-09
Start date
2024-02-25
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Intraoperative high-flow cerebrospinal fluid leakage

Interventions

one:in situ bone flap reconstruction
two:no in situ bone flap

Sponsors

The First Affiliated Hospital, the Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 70 years. 2. Signed the informed consent form (ICF). 3. Willingness to cooperate in completing the clinical study. 4. Possession of complete medical records, clear surgical indications, completion of preoperative evaluations, and exclusion of surgical contraindications. 5. Intraoperative occurrence of high-flow CSF leakage (defined as extensive subarachnoid space exposure or ventricular/cisternal exposure, with a dural defect >=1 cm²).

Exclusion criteria

Exclusion criteria: 1. Preoperative presence of severe intracranial infection. 2. Severe psychiatric or neurological disorders impairing the ability to independently comply with postoperative management and follow-up. 3. Limited life expectancy due to other medical conditions, rendering completion of the study period unfeasible. 4. Active phase of allergic rhinitis or recent history of nasal surgery. 5. History of craniocerebral trauma or related surgeries. 6. Primary thyroid diseases causing abnormal hormone levels. 7. Malignancies in other organ systems.

Design outcomes

Primary

MeasureTime frame
cerebrospinal fluid rhinorrhea;intracranial infection;Tumor resection status;

Secondary

MeasureTime frame
time of operation;hospital stays;The rate of secondary surgery;Improvement in the quality of life of patients;Recovery of sense of smell;Change in vision;hormonal level;

Countries

China

Contacts

Public ContactDakuan Gao

The First Affiliated Hospital, the Fourth Military Medical University

syjgdk@126.com+86 180 9118 3236

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026