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IRCT20110514006468N2 IRCT 2021-11-21 Tehran University of Medical Sciences Comparison of piezosurgery and conventional external osteotomy post rhinoplasty morbidities (ecchymosis, edema, pain) at imam khomeini hospital, 2021_2023 Comparison of piezosurgery and conventional external osteotomy post rhinoplasty morbidities (ecchymosis, edema, pain) 2021-12-06 anticipated 60 Complete https://irct.ir/trial/58707 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: we use block randomization. we have blocks of four intervention (A) and four of control (B) groups and write them from 1-6 on cards and put them in a pocket, then choose them by chance and make a sequence of cards. We import patients of interventional or control group of our study from these sequences, Blinding description: In this study patients, (despite informed consent) will not realize their group. In this study post operation assessors will not know the patients group. N/A Rhinoplasty post operation morbidities (edema, ecchymosis, pain). Intervention 1: Intervention group: In this group we will do external osteotomy with piezoelectric device ( POEZOTOME M+ ( The ultrasonic expert )) of COMEO company with engine speed 36-28 Khz with 90 angled straight blade (RHS5) and after external incisor (max use of each blade: 3 patient). Other parts of surgery is completely same with control group. Intervention 2: Control group: In this group we will do external osteotomy with conventional 2 millimeter straight blade. 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 Amin Amali
Imam Khomeini hospital complex , Bagherkhan Ave, South Chamran highway
Tehran Iran (Islamic Republic of) 141765371 982161190 zohreh.ghasemii92@gmail.com Tehran University of Medical Sciences scientific Amin Amali
South Chamran highway, Bagherkhan Blv, Imam Khomeini hospital complex
Tehran Iran (Islamic Republic of) 141765371 00982161190 ZOHREH.GHASEMII92@GMAIL.COM Tehran University of Medical Sciences Iran (Islamic Republic of) patient consent patient without any contraindication for rhinoplasty 18 years 50 years Both revision surgery severe deformities anticoagulant medication users past medical history current smokers Treatment - Surgery Treatment - Surgery Intervention group: In this group we will do external osteotomy with piezoelectric device ( POEZOTOME M+ ( The ultrasonic expert )) of COMEO company with engine speed 36-28 Khz with 90 angled straight blade (RHS5) and after external incisor (max use of each blade: 3 patient). Other parts of surgery is completely same with control group. Control group: In this group we will do external osteotomy with conventional 2 millimeter straight blade. Post rhinoplasty edema. Timepoint: 4 and 7 day after surgery. Method of measurement: Kara and Gökalan (Adopted by Yucel). Post rhinoplasty ecchymosis. Timepoint: 4 and 7 day after surgery. Method of measurement: Kara and Gökalan (Adopted by Yucel). Pain. Timepoint: 4 and 7 day after surgery. Method of measurement: 10 point pain ruler scale. Tehran University of Medical Sciences Approved 2021-09-14 Ethic committee of Tehran university of medical sience Vice chancellery for research and technology of Tehran university of medical sience, , Qods Ave, Keshavarz Blv Tehran Tehran Iran (Islamic Republic of)