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 | Completed

• 1 other identifier: Bioethics Comm. MMC (232/22)
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Rhinosinusitis Chronic; Bleeding

Keywords

bleeding; boezaart scale; saline irrigation; surgical endoscopic visibility; fess

Outcome Measures

Primary Outcomes (1)

• Total intraoperative bleeding

  The effect of intraoperative irrigation with hot 0.9% NaCl on total intraoperative blood loss during FESS, compared with room-temperature NaCl irrigation and no irrigation, that will be measured in mililiters (ml).

  From the beginning until the end of the surgery

Secondary Outcomes (2)

• Surgical field visibility

  From the beginning of the operation until the end.

• The effect of intraoperative irrigation with hot 0.9% NaCl surgical field visibility and blood loss per minute of operative time during FESS, compared with room-temperature NaCl irrigation and no irrigation.

  From the beginning to the end of surgery.

Study Arms (3)

Hot Saline Irrigation

EXPERIMENTAL

Participants undergoing functional endoscopic sinus surgery (FESS) will receive intraoperative irrigation with 0.9% sodium chloride solution heated to 50°C at 10-minute intervals during surgery.

Procedure: Hot saline irrigation

Room-Temperature Saline Irrigation

EXPERIMENTAL

Participants undergoing FESS will receive intraoperative irrigation with 0.9% sodium chloride solution at room temperature (22°C).

Procedure: Room-temperature saline irrigation

Control Group

NO INTERVENTION

Participants undergoing FESS without intraoperative saline irrigation.

Interventions

Hot saline irrigation PROCEDURE

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

Hot Saline Irrigation

Room-temperature saline irrigation PROCEDURE

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

Also known as: 2

Room-Temperature Saline Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Military Institute of Aviation Medicine: lead

Study Sites (1)

Military Institute of Aviation Medicine

Warsaw, Mazovian, 01-755, Poland

Location

Related Publications (4)

• Altaf J, Ashfaq AH, Riaz N, Arshad M, Ayub N, Rehman A, Maqbool S. Effect of hot saline irrigation on the operative field during endoscopic sinus surgery: a randomized controlled trial. Eur Arch Otorhinolaryngol. 2025 Jan;282(1):235-240. doi: 10.1007/s00405-024-09005-0. Epub 2024 Oct 1.

  PMID: 39354187 BACKGROUND

• Stangerup SE, Thomsen HK. Histological changes in the nasal mucosa after hot-water irrigation. An animal experimental study. Rhinology. 1996 Mar;34(1):14-7.

  PMID: 8739861 BACKGROUND

• Nagarajah D, Kueh YC, Lazim NM, Abdullah B. The hemostatic effect of hot saline irrigation in endoscopic sinus surgery: a systematic review and meta-analysis. Syst Rev. 2022 Nov 18;11(1):246. doi: 10.1186/s13643-022-02113-0.

  PMID: 36401259 BACKGROUND

• Al-Qudah MA. The effect of intranasal irrigation with epinephrine solution on intraoperative visualization and bleeding during FESS. Eur Arch Otorhinolaryngol. 2022 Apr;279(4):1911-1917. doi: 10.1007/s00405-021-06952-w. Epub 2021 Jun 27.

  PMID: 34175968 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Agnieszka Witkowska-Janik, MD, PhD

  Military Institute of Aviation Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 4, 2026
• Study Start: March 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: May 28, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)