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An Observational Study on Absorbable Polymer Tissue Sealant Membrane in Preventing Cerebrospinal Fluid Leakage After Endoscopic Endonasal Surgery

An Observational Study on Absorbable Polymer Tissue Sealant Membrane in Preventing Cerebrospinal Fluid Leakage After Endoscopic Endonasal Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109545
Enrollment
Unknown
Registered
2025-09-22
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Skull base diseases

Interventions

Absorbable polymer tissue sealant membrane group:None
Control group:None

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: The absorbable polymer tissue sealing film group was selected as the standard 1. Age greater than or equal to 18 years old and less than 85 years old; 2. Cerebrospinal fluid leakage and low flow during nasal endoscopic surgery due to skull base disease, Kelly grade 1-2; 3. Signed informed consent form. 4. Patients who have actually used absorbable polymer tissue sealing membrane therapy according to the investigator's routine treatment practice decision. Control group selection criteria 1. Age greater than or equal to 18 years old and less than 85 years old; 2. Cerebrospinal fluid leakage and low flow during nasal endoscopic surgery due to skull base disease, Kelly grade 1-2; 3. Signed the informed consent form for the collection and preservation of biological and information resources in Huashan Hospital Affiliated to Fudan University; 4. Patients who have actually used artificial meningeal or autologous fat or fascial tamponade therapy according to the investigator's decision of routine treatment practice. 5. Patients who have been followed up for long-term postoperative review and follow-up at Huashan Hospital Affiliated to Fudan University and have generated the disease course and related follow-up information required for the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria for absorbable polymer tissue sealing membrane group 1. Cerebrospinal fluid leakage and high flow after nasal endoscopic surgery Kelly >=3 grade; 2. History of recurrent sinusitis, otitis media, and migraine; 3. Have a history of falling to skull base fracture or open head injury in the past six months, or have undergone external ventricular drainage or craniotomy in the past six months; 4. Study participants with hydrocephalus at the time of inclusion; 5. Those with severe infection, anemia (Hb=3 grade; 2. History of recurrent sinusitis, otitis media, and migraine; 3. Have a history of falling to skull base fracture or open head injury in the past six months, or have undergone external ventricular drainage or craniotomy in the past six months; 4. Study participants with hydrocephalus at the time of inclusion; 5. Those with severe infection, anemia (Hb<60g/L), hypoproteinemia (Alb<30g/L); 6. Study participants with impaired coagulation due to drugs or other reasons; 7. Those with malignant tumors and cachexia; 8. Patients with autoimmune diseases or those who use immunosuppressants; 9. Pregnant or lactating women; 10. The investigator thinks it is inappropriate.

Design outcomes

Primary

MeasureTime frame
Postoperative CSF leakage;

Secondary

MeasureTime frame
Postoperative intracranial infection;Postoperative intracranial pneumatosis;Postoperative sinusitis;

Countries

China

Contacts

Public ContactYongfei Wang

Huashan Hospital Affiliated to Fudan University

eamns@hotmail.com+86 130 0313 1812

Outcome results

None listed

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