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IRCT20200810048356N1 IRCT 2020-09-29 Kashan University of Medical Sciences Effect of mytomycin on relapsed nasal polyposis The effect of topical mitomycin in patients with relapsed nasal polyposis 2020-07-31 anticipated 40 Complete https://irct.ir/trial/50328 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization with quadruple blocks was assigned to two groups. An external site - Sealed Envelope - has been used for randomisation. In this site using random numbers we assigned 40 numbers to two groups of A and B. Then , using the above list patients were referred to the assigned groups , respectively. For example, if in the mentioned list, the No.1 and 2 are in group A and the No. 3 is in group B, the first and the second patient will be in group A and the third patient will be in group B. 3 Recurrence of nasal polyps. Intervention 1: Intervention group: During this trial, at the end of surgery, in one group, cotton mesh impregnated with 1.5 cc of mitomycin 0.1 mg / ml is placing in the nasal cavity for 5 minutes. In this study, the Mitonco, product of KOREA UNITED PHARM Inc is using. Intervention 2: Control group: At the end of the surgery, cotton mesh impregnated with 1.5 cc of normal saline is placing in the frontal sinus and inside the maxillary, ethmoid and sphenoid sinus, for five minutes as a placebo. 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 DR Amirhossein Ahsani Arani
No. 5 Iman 4 Bahonar Blvd. Moallem Square
Kashan Iran (Islamic Republic of) 8714869483 +98 31 5557 0331 fatemeh.ffty@gmail.com Kashan University of Medical Sciences scientific Dr Amirhossein Ahsani Arani
No. 5 Iman 4 Bahonar Blvd. Moallem Square
Kashan Iran (Islamic Republic of) 8714869483 +98 31 5557 0331 fatemeh.ffty@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Recurrence of nasal polyps after one or more surgery 16 years 60 years Both People with systemic diseases such as diabetes and high blood pressure All patients with underlying disorders including cystic fibrosis, kartagener, respiratory ciliary mobility disorder Treatment - Drugs Placebo Intervention group: During this trial, at the end of surgery, in one group, cotton mesh impregnated with 1.5 cc of mitomycin 0.1 mg / ml is placing in the nasal cavity for 5 minutes. In this study, the Mitonco, product of KOREA UNITED PHARM Inc is using. Control group: At the end of the surgery, cotton mesh impregnated with 1.5 cc of normal saline is placing in the frontal sinus and inside the maxillary, ethmoid and sphenoid sinus, for five minutes as a placebo. The symptoms in the two groups of study will be determined and compared before surgery and one and six months after that, as the outcome of this clinical trial by questionnaire. Evaluation of the patient's clinical symptoms in this questionnaire that is based on Rhinosinusitis Symptom Inventory System will be made and scored before and after the treatment. Timepoint: Before surgery and one and six months after that by questionnaire. Method of measurement: Questionnaire based on Rhinosinusitis Symptom Inventory System. Kashan University of Medical Sciences Approved 2020-07-27 Ethics Committee of Kashan Medical University No. 5, Iman St., Bahonar Blvd., Moallem Blvd., Kashan Kashan Isfehan Iran (Islamic Republic of)