Actively Recruiting
NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery
Led by Maria Sklodowska-Curie National Research Institute of Oncology · Updated on 2025-10-14
225
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 synthetic agents (PEI/PEG) is widespread in surgical practice, however, recent high-quality evidence challenges their clinical benefit and cost-effectiveness. This study aims to investigate whether the routine use of sealants in patient with peri-operatively assessed low CSF leak risk, significantly improves outcomes over no sealant use, to guide more cost- effective, evidence-based closure strategies. To the best of our knowledge, the present study is the first randomized clinical trial to evaluate the necessity and comparative effectiveness of fibrin and synthetic sealants versus no sealant in preventing postoperative CSF leaks following endoscopic endonasal surgery in low-post operative CSF leak risk patients.
CONDITIONS
Official Title
NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for endoscopic endonasal surgery involving standard skull base reconstruction
- Provided informed written consent before enrollment
- Hemodynamically and electrolytely stable before surgery
- Procedure expected to be completed without using high-flow intraoperative CSF diversion techniques
You will not qualify if you...
- Revision surgery or extended endoscopic approaches needing complex reconstruction
- 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 with HbA1c over 7.0%
- Participation in another interventional trial affecting wound healing or CSF assessment
- Radiologic signs of chronic intracranial hypertension or hypotension
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Maria Sklodowska-Curie Institute - Oncology Center
Warsaw, Poland
Actively Recruiting
Research Team
W
Wojciech Czyzewski, MD PhD, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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