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IRCT20220510054810N1 IRCT 2023-05-21 Iran University of Medical Sciences •" Investigating the Effect of Betamethasone Ophthalmic Ointment in Reducing the Recurrence of Polyposis After Frontal Sinus Surgery" • Investigating the Results of Betamethasone Ophthalmic Ointment in Polypoid Frontal Sinus in Endoscopic Sinus Surgery and Its Effect in Reducing the Recurrence of Polyposis After Surgery 2022-09-23 anticipated 30 Complete https://irct.ir/trial/63655 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling is by random number generation method so that right frontal sinus is selected with odd numbers and left frontal sinus with even numbers, Blinding description: Patients know that betamethasone ointment is used in sinus surgery, but they don't know if it is left or right. The evaluator of the result does not know which side the betamethasone ointment was used on. N/A Polyp recurrence after sinus surgery. Intervention 1: Intervention group: 30 patients with bilateral frontal sinus polyps are selected according to the initial CT scan. Right or left sinus is randomly selected as intervention group. Betamethasone ophthalmic ointment of Iran Najo Pharmaceutical Company 0.1%, 3 grams is used in all patients, which contains 3 milligrams of corticosteroids. After performing Draf 2a surgery in both the control and interventional frontal sinuses in all patients, 3 grams of betamethasone ophthalmic ointment is placed inside the frontal sinus suction and enters the interventional side at the end of the surgery. Ointment is not used in the control sinus. In post-surgery treatment, patients receive budesonide intranasal corticosteroid spray every 12 hours and washing serum. None of the patients receive oral corticosteroids after surgery. Intervention 2: Control group: In this group, during endoscopic sinus surgery, only polyps are removed, and we perform draf 2 a surgery. Betamethasone ointment is not used. Yes - There is a plan to make this available What will be shared: Information About Age and Gender and the Results of Endoscopy and CT Scan Will Be Published. When: 3 Months After the Publication of the Results To whom: Researchers Conditions: For research Where to obtain: Zeinab Emamgholizadeh e- mail address: L.med.tbz90@gmail.com How to obtain: After receiving the email, the requested items will be sent immediately to the email of the document requester. e-mail address : L.med.tbz90@gmail.com Comments:
public Zeinab Emamgholizadeh
Iran University of Medical Sciences., Shahid Hemmat Highway.,Tehran., IRAN
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 info@iums.ac.ir Iran University of Medical Sciences scientific Zeinab Emamgholizadeh
Iran University of Medical Sciences., Shahid Hemmat Highway.,Tehran., IRAN
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 L.med.tbz90@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Bilateral Polypoid Frontal sinus The size of the frontal sinuses should be approximately the same in each patient. No allergy to corticosteroides no limit no limit Both Previous surgery of the frontal sinus Allergy to corticosteroides Treatment - Drugs Treatment - Surgery Intervention group: 30 patients with bilateral frontal sinus polyps are selected according to the initial CT scan. Right or left sinus is randomly selected as intervention group. Betamethasone ophthalmic ointment of Iran Najo Pharmaceutical Company 0.1%, 3 grams is used in all patients, which contains 3 milligrams of corticosteroids. After performing Draf 2a surgery in both the control and interventional frontal sinuses in all patients, 3 grams of betamethasone ophthalmic ointment is placed inside the frontal sinus suction and enters the interventional side at the end of the surgery. Ointment is not used in the control sinus. In post-surgery treatment, patients receive budesonide intranasal corticosteroid spray every 12 hours and washing serum. None of the patients receive oral corticosteroids after surgery. Control group: In this group, during endoscopic sinus surgery, only polyps are removed, and we perform draf 2 a surgery. Betamethasone ointment is not used. Polyp recurrence. Timepoint: After surgery, two visits are performed, the first one after one and a half months and the second one after three months in order to check the endoscopic parameters including polyps/inflammation/discharges and CT scan indicators of the sinuses. Method of measurement: Using endoscopic examination and polyp, inflammation, discharge ( PID) criteria and sinus CT scan to measure soft tissue density ratio (STDR). Iran University of Medical Sciences Approved 2021-04-06 Ethics committee of Iran University of Medical science Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN Tehran Tehran Iran (Islamic Republic of)