This Study Aims to Assess the Impact of 50°C Saline Irrigation on the Overall Intraoperative Bloo… (NCT07627789) | Clinical Trial Compass
CompletedNot Applicable
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.
Poland59 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total intraoperative bleeding
Timeframe: From the beginning until the end of the surgery