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

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with a pituitary adenoma or craniopharyngioma who are planned for surgery through the nose with an endoscope. It tests a device that keeps the camera lens from fogging.

Életkor

18 to 75 years

Nem

All sexes

A betegség stádiuma

Pituitary adenoma or craniopharyngioma of ≤ 3 cm (1,2 in) on MRI/CT, without extensive spread into the skull base. Planned elective endoscopic endonasal transsphenoidal surgery. General health ASA class I-III.

Korábbi kezelés

People whose earlier nose surgery prevents placing the device cannot join.

A részvétel fő kizáró okai

• Severe nose deformity, polyps or earlier nose surgery that prevents placing the device
• Active nose or body-wide infection (WBC > 10 × 10⁹/L, CRP ≥ 10 mg/L), known brain infection or ongoing CSF (brain fluid) leak
• Blood clotting problems (PT > 14 s or APTT > 45 s) or blood thinners that cannot be stopped for ≥ 7 days
• Allergy to silicone or medical-grade plastics, or a planned combined approach through the skull or eye socket
• Pregnancy or breastfeeding, or a mental or cognitive disorder that prevents consent or follow-up

A regiszter feltételei, szó szerint

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

• 18 és 75 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

• Intervention groupA vizsgált kezelés

  A single-use, sterile "anti-fog suction device" (a 4 Fr multi-channel silicone catheter) is introduced through the same nostril alongside the endoscope after induction of anaesthesia. The built-in micro-balloon is inflated with 1 ml air to anchor the tip in the posterior choana. Low-flow (2 L min-¹), filtered, room-temperature air is delivered through the central lumen, creating a gentle laminar stream that passes across the lens, continuously removing warm humid air and preventing condensation. Two side ports provide continuous low-pressure (-5 cmH₂O) suction of any blood or fluid, keeping the surgical field dry. The device remains in place for the entire operation and is removed before nasal packing. No extra incisions or sutures are required.

  Kezelés: Anti-fog suction device-a 4 Fr multi-channel silicone catheter

• Control groupNincs vizsgálati kezelés, összehasonlításként

  Standard care: whenever the lens fogs, the scrub nurse withdraws the endoscope and irrigates its tip with 5-10 ml of 37 °C sterile saline from a 20 ml syringe. This manoeuvre is repeated as often as necessary (average 10-15 times per case).