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COMPLETED
NCT07627789
NA

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.

Sponsor: Military Institute of Aviation Medicine

View on ClinicalTrials.gov

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.

Official title: Hot Saline Irrigation on Intraoperative Bleeding and Improving Surgical Field Visibility During Functional Endoscopic Sinus Surgery: a Prospective Clinical Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2023-03-01

Completion Date

2026-05-28

Last Updated

2026-06-04

Healthy Volunteers

Yes

Interventions

PROCEDURE

Hot saline irrigation

Intraoperative irrigation of the sinonasal cavity using 0.9% NaCl heated to 50°C during FESS.

PROCEDURE

Room-temperature saline irrigation

Intraoperative irrigation of the sinonasal cavity using 0.9% NaCl at 22°C during FESS.

Locations (1)

Military Institute of Aviation Medicine

Warsaw, Mazovian, Poland