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

Обзор

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

Вмешательства

• Устройство Anti-fog suction device-a 4 Fr multi-channel silicone catheter
  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 condensatio

Первичные конечные точки

• Total duration of lens-fog interruptions (minutes) [Срок оценки: Before the Nasal Packing(2 hours roughly)]

Вторичные конечные точки (2)

• post-operative intracranial infection rate [Срок оценки: 7 days]
• Total irrigation fluid volume used intra-operatively (ml) [Срок оценки: Before the nasal packing(2 hours roughly)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT07316101 · WestChinaH-HX-2025-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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