Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060217) titled 'Using Warm Salt Water to Keep the Camera Clear During Nose Surgery' on April 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Shizuoka General Hospital

Condition: Condition - Hypertrophic rhinitis or allergic rhinitis requiring submucosal inferior turbinate bone resection Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Lens fogging during endoscopic nasal surgery significantly reduces the visibility of the surgical field, often necessitating interruptions in the procedure and frequent removal of the endoscope. These interruptions can adversely affect the continuity of the surgery and the surgeon's operational efficiency. Lens fogging is thought to result from condensation caused by the temperature difference between the endoscope lens and the humid environment inside the nasal cavity. To address this issue, both automatic endoscope cleaning systems and anti-fogging agents have been developed and are currently in use. While automatic cleaning systems are highly effective, they are expensive and often imported, which can make inventory management challenging. Anti-fogging agents, on the other hand, have a limited effect in preventing condensation due to temperature changes and may prolong surgical interruptions, increasing surgeon stress. In the field of laparoscopic surgery, the use of warmed saline for lens irrigation has been shown in multiple randomized controlled trials to significantly reduce the incidence and severity of lens fogging, thereby improving visibility and procedural continuity. The objective of this study is to apply the lens anti-fogging method using approximately warmed saline, which has demonstrated efficacy in laparoscopic surgery, to endoscopic nasal surgery and to evaluate its clinical significance. Specifically, this study aims to clarify the effects of warmed saline on lens fogging, maintenance of visibility, and smoothness of the surgical procedure in the narrow and highly humid operative field characteristic of endoscopic nasal surgery. The ultimate goal is to provide evidence supporting a simple, safe, and reproducible method for preventing endoscope lens fogging. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - warmed saline is used to clear lens fogging during endoscopic nasal surgery Interventions/Control_2 - oom-temperature normal saline is used to clear lens fogging during endoscopic nasal surgery

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients presenting with nasal discharge and nasal obstruction as their main complaints. 2.Patients undergoing submucosal inferior turbinate bone resection or posterior nasal neurectomy for the purpose of improving the above symptoms. 3.Patients aged 18 years or older at the time of consent. 4.Patients who have provided written informed consent voluntarily, after fully understanding the study and its procedures. Key exclusion criteria - 1.Patients with a history of unilateral submucosal inferior turbinate bone resection. 2.Patients with a history of unilateral laser submucosal inferior turbinate ablation. 3.Patients with a history of ligation of the common carotid artery or its branches. 4.Patients with a history of nasal or paranasal sinus cancer. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 27 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068877

Disclaimer: Curated by HT Syndication.