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IRCT20201021049095N1 IRCT 2021-09-29 Shahid Beheshti University of Medical Sciences Comparison of the effect of Budesonide nasal spray, Betamethasone nasal drop, and Budesonide nebulizing suspension on sinonasal polyposis recurrence Comparative assessment of the effect of corticosteroid in three forms of Budesonide nasal spray, Betamethasone nasal drop, and Budesonide nebulizing suspension on sinonasal polyposis recurrence after the FESS 2021-09-23 anticipated 108 Complete https://irct.ir/trial/55614 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: A total of 108 patients with the study inclusion criteria were randomly assigned to three groups of 36 patients, including Budesonide nasal spray as the standard treatment in comparison with two intervention groups of Betamethasone nasal drop, and Budesonide nebulizing suspension. To begin with, one of the letters A, B, C is considered for each treatment, and Random Allocation software is used to build random blocks. The software generates 18 different blocks with size 6, according to the total sample size of 108, the blocks size of 6, and considering 3 treatment groups. There are 6 blanks in each block in which the 3 letters A, B, and C are randomly combined in different sequences, assuming that each letter is repeated twice in each block. Thus, the software output is a list of 18 blocks, each of which has 6 blanks, which are filled with different sequences of A, B, and C (each letter is repeated twice in every single block). In other words, we have a total of 18 blocks, each of which has 2 locations for every study treatment. Finally, by completing the sampling, we reach 36 patients in each of groups A, B and, C. Next, each block is placed in separate envelopes, encoded from 1 to 18. To maintain the principles of allocation concealment, the physician is not aware of the sequence inside each envelope. The envelopes are given to someone outside the research team who informs the physician about assigning each patient to treatment groups during the study. 3 Sinonazal polyposis. Intervention 1: Intervention group: Betamethasone nasal drop 0.1%- Daroopakhsh Company (3 drops on each side of the nose, once per night). In addition, Cephalexin and Lavage serum are given to the patients in all groups during the first two weeks of treatment. As well, routine corticosteroid treatment is given to all groups for up to one month after surgery. Intervention 2: Intervention group: Budesonide nebulizing suspension, with a dose of 0.25 mg/ml in BD form- AstraZeneca Company (every morning and night, ten series with a syringe inside each side of the nose). In addition, Cephalexin and Lavage serum are given to the patients in all groups during the first two weeks of treatment. As well, routine corticosteroid treatment is given to all groups for up to one month after surgery. Intervention 3: Control group: Budesonide nasal spray, 32 mcg- Razavi Pharmaceutical Services Institute (1 puff per day on each side of the nose). In addition, Cephalexin and Lavage serum are given to the patients in all groups during the first two weeks of treatment. As well, routine corticosteroid treatment is given to all groups for up to one month after surgery. Yes - There is a plan to make this available What will be shared: All data could be shared after deleting the patients' names When: Since the beginning of the data collection To whom: Researchers in academic and scientific institutions Conditions: Data could be shared if other researchers request it Where to obtain: Najmeh Rajabi How to obtain: Sending email to the researcher Comments:
public Najmeh Rajabi
Taleghani Hospital, Yaman st.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2560 najmeh.rajabi@gmail.com Shahid Beheshti University of Medical Sciences scientific Najmeh Rajabi
Taleghani Hospital, Yaman St.
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 najmeh.rajabi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) FESS candidates with sinonasal polyposis patients between 18 to 70 years old 18 years 70 years Both Absence of underlying diseases, including CF, Wegener's, Kartagener, sarcoidosis, vasculitis, or rheumatic diseases; Receiving no systemic corticosteroids for up to 4 weeks before surgery; ages below 18 or higher than 70 years olds J33.9 Nasal polyp, unspecified Prevention Prevention Prevention Intervention group: Betamethasone nasal drop 0.1%- Daroopakhsh Company (3 drops on each side of the nose, once per night). In addition, Cephalexin and Lavage serum are given to the patients in all groups during the first two weeks of treatment. As well, routine corticosteroid treatment is given to all groups for up to one month after surgery. Intervention group: Budesonide nebulizing suspension, with a dose of 0.25 mg/ml in BD form- AstraZeneca Company (every morning and night, ten series with a syringe inside each side of the nose). In addition, Cephalexin and Lavage serum are given to the patients in all groups during the first two weeks of treatment. As well, routine corticosteroid treatment is given to all groups for up to one month after surgery. Control group: Budesonide nasal spray, 32 mcg- Razavi Pharmaceutical Services Institute (1 puff per day on each side of the nose). In addition, Cephalexin and Lavage serum are given to the patients in all groups during the first two weeks of treatment. As well, routine corticosteroid treatment is given to all groups for up to one month after surgery. Recurrence. Timepoint: 1 and 6 months after surgery. Method of measurement: Diagnostic endoscopy. Degree of recurrence. Timepoint: 1 and 6 month after surgery. Method of measurement: Modified L K –SCALE endoscopy. Visual Analog Scale (VAS) for scoring the symptoms of sinusitis and polyps. Timepoint: 1 and 6 months post operation. Method of measurement: questioning from patients. Self rated satisfaction of surgery outcomes. Timepoint: 1 and 6 months post surgery. Method of measurement: questioning from patients. Need to revision. Timepoint: 1 and 6 months post surgery. Method of measurement: examination and questioning from patients. Side effects including dryness and Epistaxis. Timepoint: 1 and 6 months after surgery. Method of measurement: clinical examination. Shahid Beheshti University of Medical Sciences Approved 2021-03-15 Ethics committee of Shahid-Beheshti University of Medical Sciences Qods city, Simaye-Iran St., MOHME Tehran Tehran Iran (Islamic Republic of)