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IRCT20220104053618N1 IRCT 2022-09-23 Ahvaz University of Medical Sciences External perforating osteotomy in rhinoplasty with ultrasonic cut External perforating osteotomy in rhinoplasty comparing ultrasonic cut vs traditional osteotome: A preliminary randomized crossover clinical trial 2022-09-17 anticipated 26 Complete https://irct.ir/trial/61335 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Randomization will be done in a simple and individual way Before conducting the study on 26 patients, an envelope will be given to the patients, which will be related to the side of osteotomy with piezoelectric (right or left) and in order to be equal, interventions will be performed randomly in 13 cases on the right side and in the other 13 samples. It will be done on the left And the envelope will be randomly given to the patient, and the surgeon will take the envelope from the patient in the operating room and based on that, he will perform the selected side with piezoelectric and the opposite side with a 2 mm osteotome. The piezo osteotomy side will compare the two sides, Blinding description: Patients are selected and entered into the study without knowing which side was used for which of the two osteotomy methods, and all patients who meet the mentioned criteria are randomly admitted to the piezo osteotomy group (study group) or 2 mm osteotomy (control group). The person in charge of evaluating patients, clinical results and complications of surgery at the end of surgery and in subsequent follow-up is unaware of the grouping process and the type of osteotomy device on both sides. 3 nose deformity. Intervention 1: Intervention group: Lateral osteotomy using Action piezoelectric device made in France on a sample of 26 person under general anesthesia after 7-10 minutes of injection of lidocaine containing adrenaline 1:100,000 randomly on one side with piezoelectric using a small angle pen head Dar PZ3 with washing 100 ml per minute and mode D2 externally through 2 2 mm skin incisions; The first incision will be made in the caudal area and the second incision will be made 8-10 mm more medial than the medial canthus without lifting the periosteum. Intervention 2: In the control side, the 2-mm wide sharp osteotomes was used on a sample of 26 person under general anesthesia after 7-10 minutes of injection of lidocaine containing adrenaline 1:100,000 randomly on the side opposite to the intervention side (for example, if osteotomy with piezo On the right side, the osteotomy will be performed with the traditional method on the left side and this procedure will be performed randomly on both sides) with a traditional perforating technique. 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 The assistant professor has not given opinion to broadcast this information
public بهاره یعقوبی
No. 48 , West Sepid Ave., Kian Abad St., Ahvaz
Ahvaz Iran (Islamic Republic of) 6155738767 +98 21 3223 4448 Bahareh_yaghoobi@yahoo.com Ahvaz University of Medical Sciences scientific Kazem Khiabani Savojbolaghchi
School of Dentistry, Jondishapour Medical Science University, Golestan Highway, Ahvaz
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3320 5169 khiabani_ak@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) age over18 years old patients without any diseases 18 years 40 years Both history of rhinoplasty deviation respiratory problems narrow dorsum Q30.9 Congenital malformation of nose, unspecified Treatment - Surgery Treatment - Surgery Intervention group: Lateral osteotomy using Action piezoelectric device made in France on a sample of 26 person under general anesthesia after 7-10 minutes of injection of lidocaine containing adrenaline 1:100,000 randomly on one side with piezoelectric using a small angle pen head Dar PZ3 with washing 100 ml per minute and mode D2 externally through 2 2 mm skin incisions; The first incision will be made in the caudal area and the second incision will be made 8-10 mm more medial than the medial canthus without lifting the periosteum. In the control side, the 2-mm wide sharp osteotomes was used on a sample of 26 person under general anesthesia after 7-10 minutes of injection of lidocaine containing adrenaline 1:100,000 randomly on the side opposite to the intervention side (for example, if osteotomy with piezo On the right side, the osteotomy will be performed with the traditional method on the left side and this procedure will be performed randomly on both sides) with a traditional perforating technique. Eyelid ecchymosis. Timepoint: Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation. Method of measurement: Kara and Gökalan classification system for ecchymosis: grade 1: ecchymosis of the medial third of the upper or lower eyelid or both - grade 2: bruising of the medial two thirds of the upper or lower eyelid or both - grade 3: bruising of the entire length of the upper or lower eyelid or both. Eyelid edema. Timepoint: Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation. Method of measurement: Kara and Gökalang's classification system for swelling: Grade 1: no pupil covering interference by Hagrid's eyelids - 2: little pupil covering by eyelid swelling - Grade 3: complete pupil covering by significant swelling of Hagrid's eyelids 4: complete closure of the eyes. Subconjunctival hemorrhage. Timepoint: Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation. Method of measurement: Classification system for open and Gökalan Subconjunctival hemorrhage: grade 1: presence of Subconjunctival hemorrhage up to 50% of the congeal surface - grade 2: presence of Subconjunctival hemorrhage with 90% of the congeal surface. Pain. Timepoint: Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation. Method of measurement: Pain will be evaluated using a visual analog scale (VAS), in this way, the patient will be given a line marked from 0 to 10, and during three days, he will mark his pain level on the right and left side separately. It means that the number 0 indicates no pain and 10 is the highest value. Bleeding. Timepoint: During the operation and immediately post operation. Method of measurement: visual. Scar. Timepoint: Skin scars will be evaluated one month after surgery. Method of measurement: The two sides will be compared visually. Force for the mobilization of nasal bones. Timepoint: During operation. Method of measurement: Comparison of the amount of pressure required to mobilization of the nasal bones on two sides. Uniformity of the osteotomized wall. Timepoint: During operation. Method of measurement: Absence of spores on touch. Mucosal injury. Timepoint: immediate post operation. Method of measurement: examined endoscopically. Bruising and edema. Timepoint: Immediate Post operation. Method of measurement: Visually. Ahvaz University of Medical Sciences Approved 2022-09-11 Ethics committee of Ahvaz University of medical sciences Golestan st. ,Ahvaz , Iran Ahvaz Khouzestan Iran (Islamic Republic of)