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IRCT20170531034256N3 IRCT 2020-02-04 Shahid Beheshti University of Medical Sciences Effect of two treatment protocols of balloon dilatation and administration of methotrexate in tracheal stenosis due to intubation Comparison of the Effectiveness of two treatment protocols of balloon dilatation and administration of methotrexate as an auxiliary treatment for patients with tracheal stenosis due to intubation 2019-03-21 anticipated 10 Complete https://irct.ir/trial/43824 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to groups 1 or 2 , using a single computer-generated (nQuery Advisor) random number sequence by a physician, Blinding description: A statistician will classify the patients using a single computer-generated (nQuery Advisor) random number sequence in either group one (control group) or group 2 (intervention group). This person is unaware of the type of treatment which they will receive in each group. Patients will be informed about two potential types of treatment but they won't know they will receive which of those. 3 patients with tracheal stenosis due to intubation. Intervention 1: Intervention group: Methotrexate will be used every two weeks and patients will be followed every week in the first month and then at month 3 and 6. Intervention 2: Control group: They will undergo local anesthesia and sedation and then bronchoscopy immediately before performing the dilatation balloon, with the aim of determining the location of the stenosis and designing the protocol for the patients. After the last balloon dilation, patients will be monitored for 2-4 hours. 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 No more information
public Negar Bandegani
Masih Daneshvari Hospital, Darabad Avenue
Tehran Iran (Islamic Republic of) 19569-44413 +98 21 2712 2031 Fatemehrazavi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Arda Kiani
Masih Daneshvari Hospital, dar abad
tehran Iran (Islamic Republic of) 19569-44413 +98 21 2712 2031 ardakiani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with a diagnosis according to the results of medical and paraclinical examinations Patients with tracheal stenosis caused by intubation no limit no limit Both congenital tracheal stenosis as well as tracheal stenosis are excluded. Patients with tracheal stenosis due to primary or metastatic malignancies Patients with tracheal stenosis due to vasculitis such as Wegener's disease J39.8 Other specified diseases of upper respiratory tract Treatment - Drugs Treatment - Devices Intervention group: Methotrexate will be used every two weeks and patients will be followed every week in the first month and then at month 3 and 6. Control group: They will undergo local anesthesia and sedation and then bronchoscopy immediately before performing the dilatation balloon, with the aim of determining the location of the stenosis and designing the protocol for the patients. After the last balloon dilation, patients will be monitored for 2-4 hours. Need for surgical treatment at follow-up. Timepoint: Every week in the first month- month 3- month 6. Method of measurement: Physician diagnosis. Side effects. Timepoint: every week in the first month- month 3- month 6. Method of measurement: Interview - Examination. Shahid Beheshti University of Medical Sciences Approved 2020-01-21 Ethics committee of National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid B Masih Daneshvari Hospital, DAR ABAD Tehran Tehran Iran (Islamic Republic of)