Turbinates
Conditions
Interventions
This is a randomized, controlled, parallel-group clinical trial with single-blind outcome assessment. The study will include 150 adult participants undergoing septoplasty combined with partial inferio
Sponsors
Universidade Federal de São Paulo - UNIFESP/EPM
Universidade Federal de São Paulo - UNIFESP/EPM
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes, aged 18 to 60 years; diagnosis of nasal obstruction caused by nasal septal deviation associated with inferior turbinate hypertrophy; indication for septoplasty combined with partial inferior turbinectomy; provision of written informed consent through signing of the Informed Consent Form
Exclusion criteria
Exclusion criteria: Previous nasal and/or paranasal sinus surgery; other chronic sinonasal conditions, including chronic rhinosinusitis with nasal polyps and chronic rhinosinusitis without nasal polyps; current tobacco smoking; electronic cigarette use; cessation of tobacco smoking or electronic cigarette use within the previous six months; active infection at the time of surgery; pregnancy; breastfeeding; known allergy to any component of the irrigation solutions or devices used in the study; immunosuppression; autoimmune diseases; chronic use of systemic corticosteroids; reduced ability to detect sweet taste, defined as a score lower than 25 millimeters on a 0 to 100 millimeter Visual Analog Scale for sweetness intensity during the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported nasal obstruction assessed using a Visual Analog Scale (0–100 mm), recorded in a printed diary from postoperative day 1 (D1) to day 14 (D14), independently compared among different nasal irrigation devices and among different nasal irrigation solutions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evolution of other self-reported nasal symptoms (rhinorrhea, nasal dryness, and otalgia during irrigation), assessed daily using a 0–100 mm Visual Analog Scale in a printed diary from postoperative day 1 (D1) to day 14 (D14), compared between devices and between solutions; Adherence to the nasal irrigation regimen, measured by self-reported frequency in the printed diary, considering the number of irrigations performed daily between D1 and D14, evaluated between devices and between solutions; Endoscopic healing of the nasal cavities, measured using an endoscopic score applied at postoperative visits on D7 (±2 days) and D14 (±2 days), compared between devices and between solutions; Nasal mucociliary function, assessed using the saccharin test on postoperative day 14 (±2 days), compared between devices and between solutions; Time to clinically relevant improvement in self-reported nasal obstruction, defined as the first day on which the participant achieves a reduction greater than or equal to 12.5 mm on the Visual Analog Scale, compared between devices and between solutions; Acceptability of irrigation devices and solutions, assessed on D14 using a questionnaire adapted from the Theoretical Framework of Acceptability (TFA). | — |
Countries
BR
Contacts
Public ContactIgor Batista
Universidade Federal de São Paulo - UNIFESP/EPM
Outcome results
None listed