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NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery

RecruitingNAAges 18 Years - anyAllMaria Sklodowska-Curie National Research Institut…
NCT07216157 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 le

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📋 Eligibility rules (as published)
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 intraoperative CSF diversion techniques Exclusion Criteria: * 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
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What it tests

  • Standard multilayer closure without sealant
  • Fibrin sealant application
  • Synthetic polyethylene glycol-based sealant
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Where

1 site
Maria Sklodowska-Curie Institute - Oncology Center
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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