NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery
Recruiting
N/A
Interventional Study
CerebroSpinal Fluid (CSF) Leak
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 225 (estimated)
- Sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology · Other
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About This Trial
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 rou…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Contacts