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IRCT20220111053690N1 IRCT 2022-05-01 Tehran University of Medical Sciences The effect of application of dexamethasone in the middle ear during surgery The effect of application of dexamethasone in the middle ear during stapedotomy on hearing results of patients with otosclerosis 2022-04-21 anticipated 22 Complete https://irct.ir/trial/61211 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is block. Four blocks are defined from intervention group (A) and control (B). (AABB, ABAB, ABBA, BABA, BAAB) It is written on cards 1 to 6 and the cards are placed in the envelope. The cards are then randomly selected and a random string is made from the sequence of selected cards. Patients in the intervention and control groups are included in the study based on this sequence, Blinding description: . The study is single blind. The surgeon and researcher are aware of the groups but the patient and the data monitoring committee are kept blind. 3 otosclerosis. Intervention 1: Intervention group: In the control group, routine stapedotomy will be performed, and in the intervention group, immediately after perforation of the footplate by the perforator, 0.3 cc of dexamethasone will be placed in the middle ear and on the oval window, and a Teflon piston or titanium prosthesis will be placed inside the oval window. Will be placed. The area around the prosthesis in the oval window will be covered with fat removed from the lobule, and without placing the foam gel in the middle ear, the flap will be returned and the canal foam gel will be embedded. Intervention 2: Control group: routine stapedotomy will be performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Behrooz Amirzargar
Emam Khomeini Hospital, Keshavarz Blvd
tehran Iran (Islamic Republic of) 1145765111 +98 21 6119 0000 amirzargarb@yahoo.com Tehran University of Medical Sciences scientific Behrooz Amirzargar
Emam Khomeini Hospital, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1145765111 +98 21 6119 0000 amirzargarb@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with otosclerosis whose conductive hearing impairment exceeds 30 dB on recent audiometry in the affected ear no limit no limit Both Patients who have a history of previous stapedotomy surgery a history of other ear diseases, such as meningitis or upper semicircular canal dehiscence will be excluded if they do not return within the specified time after surgery. H80 Otosclerosis Treatment - Surgery Treatment - Surgery Intervention group: In the control group, routine stapedotomy will be performed, and in the intervention group, immediately after perforation of the footplate by the perforator, 0.3 cc of dexamethasone will be placed in the middle ear and on the oval window, and a Teflon piston or titanium prosthesis will be placed inside the oval window. Will be placed. The area around the prosthesis in the oval window will be covered with fat removed from the lobule, and without placing the foam gel in the middle ear, the flap will be returned and the canal foam gel will be embedded. Control group: routine stapedotomy will be performed. Hearing improvement after dexamethasone use during middle ear surgery in otosclerosis in patients with a gap of 30 dB. Timepoint: Before and 6 months after complete high frequency audiometric stapedotomy at the audiometry center. Method of measurement: Audiometry and questionnaire. Tehran University of Medical Sciences Approved 2022-03-19 Research Ethics Committees of Amir A'lam Hospital Complex Amir A'lam hospital, North Sa'di Ave , Darvaze Dolat tehran Tehran Iran (Islamic Republic of)