Polyp of Ethmoidal Sinus, Surgery
Conditions
Keywords
Saline Solution, Isotonic / Administration & dosage, Therapeutic Irrigation / methods, Postoperative Care / methods, Quality of life
Brief summary
The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at 14 days post-surgery.
Detailed description
This is a comparative study between two postoperative treatments following ethmoid sinus surgery. The purpose of this study is to compare the effect of RESPIMER® NetiFlow® solution on nasal tissue repair versus saline solution (0.9% NaCl), the standard treatment. The type of surgery selected for this study is total endoscopic ethmoidectomy. This is a frequently used standard surgery that requires nasal cleansing for an average of 28 days. This process allows the regeneration of the nasal epithelial lining of the wound (areas of exposed bone), as well as the healing of swelling and scarring due to the surgery. The follow up last 28 days with 4 visits (D7, D14, D21 and D28). RESPIMER® NetiFlow® : device of class I, with CE mark, in the indication of sinus postoperative care.
Interventions
OTHERA postoperative care after ethmoid sinus surgery
A comparison of two products used for nasal cavity cleansing, at the rate of 4 washes/day (240mL per wash), as local postoperative care following endoscopic sinus surgery. This surgery, known as an ethmoidectomy, aims to improve sinus ventilation, treat the chronically infected area, and remove polyps that cause nasal obstruction. Detailed information concerning the purpose of nasal irrigation, as well as how to use and clean the device, will be given to patients upon inclusion. The nasal washing procedure will be as follow: * Washing both nostrils using 180mL of solution distributed equally on each side to remove crusting and clotting * Gentle blowing of the nose * Rinsing both nostrils with the remaining 60mL of solution distributed equally on each side (no nose-blowing).
Sponsors
Laboratoire de la Mer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males or females between 18 and 65 years of age * Subject in need of sinus surgery as bilateral total ethmoidectomy using an endoscopic endonasal approach whose pathology is the result of a: * Sinonasal polyposis alone * Sinonasal polyposis associated with asthma and / or intolerance to NSAIDs * Free and informed written consent * Member or beneficiary of a social security program
Exclusion criteria
* Oral corticosteroid treatment since less than 2 months * Premenopausal women not using effective contraception (oral or intrauterine device) * Pregnant or nursing women * Uncontrolled diabetes (not treated or stabilized by treatment) * HIV-positive status * Autoimmune diseases affecting the nose and/or sinuses, immune dysfunctions (Wegener's granulomatosis, Churg-Strauss syndrome, Common Variable Immunodeficiency, sarcoidosis...), or malignant diseases (unclear histology) * All contraindication of RESPIMER® NetiFlow® * All diseases resulting in difficulty coughing or swallowing * Ongoing or past radiation treatment to the head and neck * Ongoing or recent chemotherapy (within a three-month period) * Subjects using anticoagulants * Subjects taking part in another study that includes an exclusion period coinciding with that of the run-in period of this study * Subjects placed under judicial protection * Subjects who suffer from severe physical or psychological problems and whose condition can, according to the investigator, affect compliance with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms | D14 meaning 14 days (plus or minus 3 days) after surgery | Based on a ≥8 points difference in the total RHINO QoL score between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess and compare the crusting | Pre-inclusion, D7, D14, D21 and D28 | Assess and compare the crusting with : * The number of patients with (whether or not obstruction exists) and without crusting. * How many days it takes for the crusting to disappear and/or the difference in the total number of care days |
| Assess and compare the tolerability | Pre-inclusion, D7, D14, D21 and D28 | Assess and compare the tolerability of RESPIMER® NetiFlow® versus saline solutions using a Visual Analog Scale (VAS) (burning sensation in the nose, alterations in taste and smell and epistaxis) (patient record). |
| Additional details on duration of nasal washes | D7, D14, D21 and D28 after surgery | Provide additional details on the duration of nasal washes according to the approved indication (patient record). |
| Efficacy in optimizing airway clearance and restoring respiratory health, as well as overall quality of life | Pre-inclusion, D7, D14, D21 and D28 | Compare the efficacy of RESPIMER® NetiFlow® versus saline solutions in optimizing airway clearance and restoring respiratory health, as well as overall quality of life using: * RHINO QoL scores (a self-report of nasal congestion, facial pain, anterior and posterior rhinorrhea). * NOSE nasal obstruction scores. |
| Satisfaction, convenience, ease of administration and ease of cleaning of the RESPIMER® NetiFlow® device | D7, D14, D21 and D28 after surgery | VAS numerical values assessing the RESPIMER® NetiFlow® device in terms of satisfaction, convenience, ease of administration and ease of cleaning (patient's Case report Form). |
| Assess functionality of nasal lining | D-1, D14, and D21 | Assess functionality of nasal lining by evaluating mucociliary clearance by rhinoscintigraphy for all patients in the 2 Bordeaux centers' (Bordeaux University Hospital and Saint-Augustin Private Hospital): * D-1 only for center's Bordeaux, 10 patients in each group (20 patients in total) * D14 and D21 for all Bordeaux patients', estimated at 50 patients (15 in each group and in addition the same 10 patients of the D-1 visit, in each group). |
| Efficacy in improving the trophicity of the nasal mucosa within the operated area | D14, D21 and D28 | Assess the efficacy of RESPIMER® NetiFlow® versus saline solutions in improving the trophicity of the nasal mucosa within the operated area, using a Lund-Kennedy endoscopic score (20 points). |
| Satisfaction and perceived efficacy of the nasal solution | D7, D14, D21 and D28 after surgery | VAS numerical values assessing the level of patient satisfaction and perceived efficacy in regard to the nasal solution that was used by each group (patient's Case report Form). |
Countries
France
Outcome results
None listed