Clinical Trial of an Anti-Fog Drainage Device for Endoscopic Endonasal Sellar Region Tumor Surgery

Summary

The goal of this clinical trial is to learn if the anti-fog suction device works to keep the surgical view clear during endoscopic nose-to-pituitary operations and whether it lowers the chance of brain-fluid infection. It will also learn about the safety of the device. The main questions it aims to answer are: * Does the device reduce the total time the surgeon has to stop because the lens fogs up? * What medical problems (such as nose-bleed, tube blockage, or infection) do participants have when the device is used? Researchers will compare the anti-fog device to the usual "water-squirt" method to see if the device works better. Participants will: * Have either the device or the usual water method applied during their planned pituitary surgery * Stay in the hospital for the normal recovery period (about 3-5 days) and return for a routine check-up around day 7 * Allow the study team to record operating times, any fog-related pauses, and results of blood or spinal-fluid tests taken before and after surgery

Eligibility

Inclusion Criteria:

* Age 18-75 years
* Pre-operative MRI/CT diagnosis of pituitary adenoma or craniopharyngioma ≤ \*3 cm without extensive skull-base invasion
* Scheduled for elective endoscopic endonasal transsphenoidal resection
* ASA physical status I-III
* Able and willing to give written informed consent and comply with follow-up

Exclusion Criteria:

* Severe nasal anatomical deformity, polyps, or prior nasal surgery preventing device placement
* Active nasal or systemic infection (WBC \> 10 × 10⁹/L, CRP ≥ 10 mg/L)
* Known intracranial infection or ongoing CSF leak
* Coagulopathy (PT \> 14 s or APTT \> 45 s) or anticoagulation that cannot be stopped ≥ 7 days
* Allergy to silicone or medical-grade plastics
* Planned combined transcranial or transorbital approach
* Pregnancy or breastfeeding
* Psychiatric or cognitive disorder precluding informed consent or follow-up

Conditions3

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