Effectiveness of Endonasal Polymeric Implant for Chronic Rhinosinusitis
Rhinosinusitis Chronic
About this trial
This is an interventional treatment trial for Rhinosinusitis Chronic
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic rhinosinusitis undergoing endoscopic sinus surgery, but who do not have the disease under control. The uncontrolled disease and its respective classification regarding the degree of the disease will be carried out through 3 assessments: 1) Nose Obstruction Symptom Evaluation Questionnaire (NOSE) validated version in Portuguese; 2) nasal endoscopic evaluation; and, 3) Sino Nasal Outcome Test Questionnaire (SNOT-22). Through the NOSE questionnaire, the patient's disease will be classified as "Controlled", "Partially Controlled" or "Uncontrolled (Uncontrolled)". Any variation in the endoscopic evaluation score based on the Lund-Kennedy Criteria will be considered an alteration. And for the SNOT-22 Questionnaire, changes will be considered when the total score varies by at least 11 points. Patients who present these 3 alterations will be considered to have the 'uncontrolled disease' and, therefore, will be eligible for the study.
Exclusion Criteria:
- Patients with malformations, trauma and/or tumors in the nasal and paranasal sinuses will be excluded;
- Patients with a history of recent nasal surgery up to 6 months previously, with glaucoma and cataracts.
Sites / Locations
- Luiz Eduardo Flório JuniorRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
L-lactide and trimethynele carbonate Terpolymers polymer implant
Placebo polymer implant
The polymer implant will be placed in the ethmoidal region, at the same time that the nasal endoscopic examination will be performed. The polymer in this study is biocompatible. The polymers will be made in the biomaterials laboratory located at the Pontifical Catholic University of São Paulo (PUC-SP), located in the city of Sorocaba-SP. Polymers will be provided free of charge for the study.
Placebo polymer implant