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IRCT20180106038248N1 IRCT 2018-01-19 Shiraz University of Medical Sciences Effectiveness of Sodium hyaluronic gel in improvement of hearing in patient with otosclrosis Comparison of Hearing Results in Stapedotomy in Patient With Otosclrosis With and Without Sodium Hyaluronic Gel. 2016-11-21 anticipated 100 Complete https://irct.ir/trial/28735 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with one person and random numbers 0 to 9, Blinding description: Those who evaluate the outcome That is, the auditory unit and Safety Committee and Data Supervision The type of material used in practice is unaware. 3 Otosclerosis. Intervention 1: Intervention group: The intervention group consisted of 50 patients with otosclerosis who had criteria for entry into the study. in these patients, sodium hyaluronate gel is used in surgery. In this method, during operation, after the prosthesis is applied, about 0.5 cc gels of sodium hyaluronate is injected around the prosthesis to prevent peri-lymph fluid leakage. Intervention 2: Control group: The control group also includes 50 patients with otosclerosis who have criteria for entering the study. In this method, during operation, after the prosthesis is applied, adipose tissue is used around the prosthesis to prevent peri-lymph fluid leakage. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Mohammad Faramarzi
Khalili hospital, Khalili Ave
Shiraz Iran (Islamic Republic of) 14336 -8 7134 +98 71 3629 1478 Faramarzi@sums.ac.ir Shiraz University of Medical Sciences scientific Mohammad Faramarzi
Khalili hospital, khalili Ave
Shiraz Iran (Islamic Republic of) 14336 71348 +98 71 3629 1470 Faramarzi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patiant with hearin loss due to otosclerosis Age 18-60 Can be fallowed up for 6 month 18 years 60 years Both Patient with stapedectomy. Other cause of hearing loss in patient that need stapes surgery. Age under 18 and over 60. Treatment - Surgery Treatment - Surgery Intervention group: The intervention group consisted of 50 patients with otosclerosis who had criteria for entry into the study. in these patients, sodium hyaluronate gel is used in surgery. In this method, during operation, after the prosthesis is applied, about 0.5 cc gels of sodium hyaluronate is injected around the prosthesis to prevent peri-lymph fluid leakage. Control group: The control group also includes 50 patients with otosclerosis who have criteria for entering the study. In this method, during operation, after the prosthesis is applied, adipose tissue is used around the prosthesis to prevent peri-lymph fluid leakage. The level of auditory hearing before and after stapedotomy using sodium hyaluronate gel compared with adipose tissue. Timepoint: audiometery befor and 21 days after surgury. Method of measurement: Audiometery. Shiraz University of Medical Sciences Approved 2018-01-15 Ethics committee of Shiraz University of Medical Sciences Shiraz university of medical sciences, zand blvd Shiraz Fars Iran (Islamic Republic of)