2.1. Study Design
adenoid hypertrophy, OME
TYMPANIC MEMBRANE RETRACTION, POLAND, ADVERSE EFFECTS, ADENOID HYPERTROPHY, MIDDLE EAR, ACUTE OTITIS MEDIA, NECK DISEASE
We conducted a pilot, single-arm trial. Our study population comprised 36 patients recruited from the Outpatient Clinic of the Department of Otorhinolaryngology, Head and Neck Diseases in Olsztyn, Poland. All patients provided written informed consent. Patients were included if they filled the following criteria:Otologic diagnosis of unilateral or bilateral OME in the otoscopy at the visit before the recruitment;At least unilateral type B, C1, or C2 tympanogram;Aged between 18 and 70 years.The exclusion criteria were:Otologic diagnosis of acute otitis media and other ear abnormalities at the visit before the recruitment;History of the active neoplastic disease;Current pregnancy;History of adenoid hypertrophy or nasal polyps.Ethical approval was obtained from the ethics committee of the University of Warmia and Mazury (reference number 16/2017). All participants gave written informed consent.Baseline characteristics of patients (age, gender, date of initial outpatient clinic visit), as well as prior medical history, were extracted from the electronic patient dataset. We collected data on adverse effects occurring during the administration of the treatment using a standard questionnaire. Nasal endoscopy was made by board-certified otolaryngologists with at least 15 years of experience. Tympanometry and otoscopy findings were recorded before and after the intervention. A normal tympanic membrane was diagnosed when no gas bubbles, exudate, or retraction were present. A pathological eardrum was identified when bubbles, middle ear exudate, or tympanic membrane retraction were noted. The intervention structure and procedures are shown in 