Clinical Trial

This Study Aims to Assess the Impact of 50°C Saline Irrigation on the Overall Intraoperative Blood Loss and Surgical Visualization During Endoscopic Sinus Surgery for Rhinosinusitis.

Completed
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Summary
Objectives: Intraoperative bleeding during endoscopic sinus surgery for severe rhinosinusitis may significantly compromise the surgical field. Saline heated to 50°C promotes transient vessel vasodilation and mucosal edema without causing nasal mucosal necrosis. The brief thermal exposure may induce superficial protein denaturation and facilitate local hemostasis, thereby improving endoscopic visibility. This study aims to assess the impact of 50°C saline irrigation on the overall intraoperative blood loss and surgical visualization during endoscopic sinus surgery for rhinosinusitis. Methods: This prospective randomized controlled trial study is going to assign the patients to three groups. In the interventional hot saline group (HSI), intraoperative irrigation will be performed with heated saline at 50°C. In the room-temperature saline group (RTSI), saline at 22°C will be used; in the third one group (Control), no irrigation will be administered. Intraoperative blood loss will be recorded in milliliters and milliliters per minute of operative time, and the surgical field will be evaluated using the Boezaart scale. HSI is hypothesized to be more effective than RTSI in minimizing intraoperative bleeding during FESS.
Trial Details
NCT Number NCT07627789
Lead Sponsor Military Institute of Aviation Medicine
Conditions Rhinosinusitis Chronic, Bleeding
Enrollment 59 participants
Start Date 2023-03-01
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-05-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-04