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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.

NCT07627789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-06-04

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Military Institute of Aviation Medicine

    lead OTHER_GOV

Principal Investigators

  • Agnieszka Witkowska-Janik, MD, PhD · Military Institute of Aviation Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-12-01
Completion
2026-05-28

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07627789 on ClinicalTrials.gov