Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT07627789

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.

Conditions: Rhinosinusitis Chronic, Bleeding

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 59
Sponsor: Military Institute of Aviation Medicine

Location: Military Institute of Aviation Medicine Warsaw Mazovian

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.

Eligibility Criteria

Inclusion Criteria: * Chronic rhinosinusitis diagnosed according to the EPOS 2020 criteria; * Confirmed failure of conservative treatment, defined as persistence of CRS symptoms for more than 12 weeks despite optimal pharmacological therapy; * Age over 18 years and ability to provide informed consent; * Written informed consent to participate in the study; * Presence of inflammatory changes on sinus computed tomography scans. Exclusion Criteria: * Lack of patient consent; * Disease limited to a single sinus; * Conditions associated with ciliary dyskinesia (e.g., cystic fibrosis); * Suspected fungal infection or fungal ball; * Poor adherence to medical recommendations or noncompliance with treatment; * Suspected neoplastic disease; * Suspected or confirmed autoimmune disorders, particularly granulomatosis with polyangiitis; * \- Confirmed or clinically suspected immunodeficiency; Diagnosed coagulation disorders or preoperative hemostasis test results outside laboratory reference ranges; Preoperative systemic glucocorticosteroid therapy.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07627789). StuddyBuddy aggregates publicly available trial information.