Status:
RECRUITING
NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
CerebroSpinal Fluid (CSF) Leak
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Postoperative cerebrospinal fluid (CSF) leak is a significant complication of endoscopic endonasal approaches (EEA) to the skull base. The use of tissue sealants such as fibrin glue (Tisseel) or synth...
Detailed Description
Introduction Postoperative cerebrospinal fluid (CSF) leak is a significant complication of endoscopic endonasal approaches (EEA) to the skull base. The use of tissue sealants such as fibrin glue (Tiss...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Scheduled for endoscopic endonasal surgery involving standard skull base reconstruction
- Informed written consent obtained prior to enrollment
- Hemodynamic and electrolyte stability before surgery
- Procedure expected to be completed without use of high-flow intraoperative CSF diversion techniques
Exclusion
- Revision surgery or extended endoscopic approaches requiring complex reconstruction (e.g., clival or cribriform defects)
- Tumors requiring complex sella reconstruction from the start
- Preoperative hydrocephalus
- Known allergy to fibrin-based or synthetic sealant components
- Active sinus infection or systemic inflammatory disease
- Prior radiotherapy to the sellar or parasellar region
- Uncontrolled diabetes mellitus (HbA1c \> 7.0%)
- Participation in another interventional trial that may influence wound healing or CSF assessment
- Radiologic signs of chronic intracranial hypertension or hypotension
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2027
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT07216157
Start Date
August 15 2025
End Date
March 15 2027
Last Update
October 14 2025
Active Locations (1)
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1
Maria Sklodowska-Curie Institute - Oncology Center
Warsaw, Poland