Effectiveness of Endonasal Polymeric Implant for Chronic Rhinosinusitis
Status:
Recruiting
Trial end date:
2022-12-15
Target enrollment:
Participant gender:
Summary
Objective: The objective of this study is to evaluate a steroid-embedded Terpolymers polymer
implant of L-lactide and trimethynele carbonate (TCM) at the level of disease control in
patients with eosinophilic and central compartment chronic rhinosinusitis (CRS) after
placement of the endonasal device, compared to a control group (placebo). The secondary
objectives of this study are to assess comfort, perception of improvement and satisfaction,
as well as adverse events.
Methods: A randomized controlled trial will be carried out, with a blinded participant,
therapist and evaluator. Patients over 18 years of age, with chronic rhinosinusitis (CRS) who
have already undergone endoscopic sinus surgery (CENS), but who do not have the disease under
control and, therefore, with an indication for a new CENS, will be selected. Participants
will come from the otorhinolaryngology outpatient clinic of the academic and public service
of the University of São Paulo - USP. Eligible patients will receive either the Terpolymers
L-lactide and trimethynele carbonate (TCM) polymer implant placement or the placebo polymer.
The primary outcome will be the control of the symptoms of chronic uncontrolled
rhinosinusitis that will be evaluated through the NOSE Questionnaire, a nasal endoscopic
evaluation based on the Lund-Kennedy criteria and the SNOT-22 Questionnaire. The sample size
calculation was performed based on a difference between the intervention and placebo groups
of 30% for cases that achieved disease control, resulting in a sample of 36 participants (18
in each group). Data will be analyzed using mixed linear models.