- ICH GCP
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- Ensaio Clínico 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.
Hot Saline Irrigation on Intraoperative Bleeding and Improving Surgical Field Visibility During Functional Endoscopic Sinus Surgery: a Prospective Clinical Study.
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Introduction Chronic rhinosinusitis (CRS) affects approximately 5-15% of the European population and significantly reduces quality of life. While pharmacological treatment, including intranasal corticosteroids, nasal irrigation, and antibiotics, may be effective in many cases, some patients will require functional endoscopic sinus surgery (FESS). Compared with traditional surgery, FESS will provide better visualization, reduced tissue trauma, fewer complications, and shorter hospitalization. However, intraoperative bleeding will remain a major challenge, as even minor bleeding may impair endoscopic visibility and increase the risk of complications. Various methods, including controlled hypotension, vasoconstrictors, corticosteroids, and reverse Trendelenburg positioning, will be used to reduce bleeding. Heated saline irrigation may also represent a useful supportive technique.
Aim This prospective study will evaluate the effect of intraoperative hot saline irrigation (HSI) on blood loss and surgical field visibility during FESS compared with room-temperature saline irrigation (RTSI) and no irrigation.
Materials and Methods Adult patients with CRS meeting EPOS 2020 criteria and requiring FESS after unsuccessful conservative treatment will be included in this randomized, patient-blinded study. Patients with fungal disease, immunodeficiency, coagulation disorders, neoplastic or autoimmune disease, or preoperative systemic steroid use will be excluded.
Participants will be randomized into three groups: HSI (0.9% NaCl at 50°C), RTSI (0.9% NaCl at 22°C), and control (no irrigation) using coin-toss allocation. Randomization will be conducted by an independent researcher not involved in surgery or postoperative assessment. Separation of responsibilities and independent surgical scheduling will be applied to reduce the risk of selection bias.
Surgical Procedure Surgical procedures will include middle meatal antrostomy, anterior and posterior ethmoidectomy, Draf I-IIa procedure, and bilateral sphenoidectomy performed without preoperative topical decongestants. A 2.7-mm Hopkins nasal endoscope (0°, 30°, 45°, or 70°; Karl Storz) and a microdebrider will be used during all procedures.
Anesthesia General anesthesia will be administered according to a standardized protocol. Anesthesia induction will be achieved with propofol, analgesia with fentanyl or remifentanil, maintenance with sevoflurane or desflurane, neuromuscular blockade with rocuronium bromide, and reversal with atropine plus neostigmine or sugammadex, depending on individual patient requirements.
Study Procedure Nasal irrigation will be performed using 0.9% NaCl at either 22°C or 50°C at least three times during surgery at 10-minute intervals. The 50°C saline solution will be stored in a laboratory incubator, while the 22°C solution will be maintained at room temperature. Irrigation will be delivered through a metal cannula connected to a syringe and inserted into the middle nasal meatus over approximately 5 seconds.
Following each irrigation, the surgical field will be evaluated using the 6-point Boezaart scale after suctioning the irrigation fluid mixed with blood from the nasopharynx. In the control group, surgical field visibility will be assessed every 10 minutes. Total blood loss will be calculated as the difference between the irrigation volume and the total suctioned fluid volume, and mean blood loss per minute will also be recorded.
The primary outcome measure will be total intraoperative blood loss. Secondary outcomes will include blood loss per minute of operative time and surgical field quality assessed using the Boezaart scale.
Data collection and analysis:
This is a pilot study; hence the statistical analysis will be completed at the end of the study.
Each participant will receive a unique study identification number to ensure anonymity and prevent the collection of directly identifiable personal data. Study data will be recorded in a Microsoft Excel database and will include demographic characteristics, comorbidities, current pharmacological treatment, Lund-Mackay CT score, CRS phenotype with or without nasal polyps, type of surgery (primary or revision), anesthetic infusion details, mean arterial pressure and pulse rate measured at 15-minute intervals, endoscopic surgical field assessment scores recorded every 10 minutes, intraoperative complications, use of a microdebrider, total intraoperative blood loss, duration of surgery, and total volume of saline irrigation used.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Mazovian
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Warsaw, Mazovian, Polônia, 01-755
- Military Institute of Aviation Medicine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Hot Saline Irrigation
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.
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Intraoperative irrigation of the sinonasal cavity using 0.9% NaCl heated to 50°C during FESS.
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Experimental: Room-Temperature Saline Irrigation
Participants undergoing FESS will receive intraoperative irrigation with 0.9% sodium chloride solution at room temperature (22°C).
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Intraoperative irrigation of the sinonasal cavity using 0.9% NaCl at 22°C during FESS.
Outros nomes:
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Sem intervenção: Control Group
Participants undergoing FESS without intraoperative saline irrigation.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Total intraoperative bleeding
Prazo: From the beginning until the end of the surgery
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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).
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From the beginning until the end of the surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Surgical field visibility
Prazo: From the beginning of the operation until the end.
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The effect of intraoperative irrigation with hot 0.9% NaCl on surgical field visibility of operative time during FESS, compared with room-temperature NaCl irrigation and no irrigation.
To measure this visibility - Boezaart score (from 0-5) will be used.
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From the beginning of the operation until the end.
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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.
Prazo: From the beginning to the end of surgery.
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The effect of intraoperative irrigation with hot 0.9% NaCl on blood loss per minute of operative time during FESS, compared with room-temperature NaCl irrigation and no irrigation.
Unit of measure: ml/min.
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From the beginning to the end of surgery.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Agnieszka Witkowska-Janik, MD, PhD, Military Institute of Aviation Medicine
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
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- Bioethics Comm. MMC (232/22)
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