Sealants or no sealant to prevent spinal fluid leak after nose-route skull base surgery

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults scheduled for endoscopic surgery through the nose to the skull base, with standard repair, and a low risk of brain fluid (CSF) leak. It compares two sealants with no sealant.

Age

18 years and older

Sex

All sexes

Disease stage

Planned endoscopic endonasal skull base surgery with standard reconstruction. Stable blood pressure, circulation and blood salts before surgery. The surgery is expected without high-flow CSF drainage techniques.

Earlier treatment

People who had prior radiotherapy to the sellar or parasellar region (area around the pituitary gland) cannot join. Repeat (revision) surgery cannot join.

Biomarker or test result

HbA1c must not be > 7.0% (53 mmol/mol) (no uncontrolled diabetes).

Main reasons for not taking part

• Revision surgery or extended approaches needing complex repair (e.g., clival or cribriform defects), or tumors needing complex sella repair
• Fluid build-up in the brain (hydrocephalus) before surgery, or scan signs of long-term high or low pressure in the skull
• Known allergy to fibrin-based or synthetic sealant components
• Active sinus infection or body-wide inflammatory disease
• Uncontrolled diabetes (HbA1c > 7.0% (53 mmol/mol)) or another interventional trial that may affect wound healing or CSF assessment

The registry criteria, word for word

What the trial wants to find out

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.

The 3 groups in the trial

• No Sealant - Standard Multilayer ClosureTreatment being tested

  Patients in this arm will receive standard multilayer closure without the use of any sealant. Closure will involve mucosal flap repositioning and hemostatic agents (e.g., Surgicel®, TachoSil®), in accordance with standard endoscopic skull base reconstruction techniques.

  Treatment: Standard multilayer closure without sealant

• Fibrin Glue - Tisseel® ApplicationTreatment being tested

  Patients will undergo standard multilayer closure followed by application of fibrin sealant (Tisseel®). This arm evaluates the effect of biologic tissue glue in preventing postoperative CSF leaks and promoting wound healing following endonasal skull base surgery.

  Treatment: Fibrin sealant application

• Synthetic Sealant - Adherus® ApplicationTreatment being tested

  This arm involves standard multilayer closure followed by the application of a two-component synthetic polyethylene glycol-based sealant (Adherus®). The objective is to evaluate the synthetic agent's efficacy and cost-effectiveness in reducing postoperative CSF leaks.

  Treatment: Synthetic polyethylene glycol-based sealant