Sealant versus no sealant to prevent CSF leaks after endoscopic endonasal skull base surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, controlled, single-center trial at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland. Adults undergoing standard endoscopic endonasal skull base reconstruction who are perioperatively judged to be at low risk for CSF leak will be randomized preoperatively into one of three arms: multilayer closure without sealant, fibrin sealant application, or a synthetic polyethylene glycol–based sealant. Outcomes will include postoperative CSF leak rates, complications, and resource use with follow-up to capture early leaks and related interventions. The goal is to determine whether routine sealant use provides measurable clinical or economic benefit over no sealant in this low-risk population.

Why it matters

Who can join: the full rules

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

Where it's running

• Maria Sklodowska-Curie Institute - Oncology Center
  Warsaw, Poland Recruiting

Study contacts

• Study coordinator: Wojciech Czyzewski, MD PhD, MD PhD
• Email: wojciech.w.czyzewski@gmail.com
• Phone: +48788599550

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.