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.
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
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
Parallel
Standard multilayer closure without sealant
Procedure/SurgeryPatients will undergo standard skull base reconstruction using mucosal flap repositioning and absorbable hemostatics (e.g., Surgicel®, TachoSil®), without application of any fibrin or synthetic sealant. This serves as the control group for comparison with sealant-assisted closures.
Fibrin sealant application
DeviceFollowing standard multilayer closure, patients in this group will receive topical application of a fibrin-based biological sealant (Tisseel®). The intervention aims to assess its effectiveness in preventing postoperative cerebrospinal fluid (CSF) leak and promoting mucosal healing after endoscopic endonasal skull base surgery.
Synthetic polyethylene glycol-based sealant
DeviceAfter standard multilayer closure, a synthetic two-component sealant (Adherus®, composed of polyethylene glycol and polyethylenimine) will be applied to reinforce the reconstruction site. This group is used to evaluate the efficacy and safety of synthetic sealant in preventing CSF leaks and supporting wound healing.
Incidence of postoperative cerebrospinal fluid (CSF) leak within 90 days
Postoperative CSF leak will be assessed clinically and endoscopically at multiple time points (Day 2, Day 30, Day 90). A leak will be defined as visible or symptomatic leakage of cerebrospinal fluid from the nasal cavity, confirmed by clinical exam and/or imaging when necessary. Assessment will be blinded and recorded using standardized diagnostic criteria.
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