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IRCT20260218068916N1 IRCT 2026-07-03 Arak University of Medical Sciences Comparison of Triamcinolone and Budesonide Nasal Irrigation after Endoscopic Sinus Surgery in Patients with Chronic Rhinosinusitis with Nasal Polyps Comparison of the Effectiveness of Triamcinolone Plus Normal Saline Nasal Irrigation versus Budesonide Plus Normal Saline Nasal Irrigation on Clinical Outcomes and Quality of Life in Patients with Chronic Rhinosinusitis with Nasal Polyps after Endoscopic Sinus Surgery 2026-07-22 anticipated 84 Recruiting https://irct.ir/trial/91356 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a randomized, parallel-group clinical trial designed to compare the effectiveness of triamcinolone plus normal saline nasal irrigation with budesonide plus normal saline nasal irrigation in patients with chronic rhinosinusitis with nasal polyps following endoscopic sinus surgery, Randomization description: Eligible participants will be randomly allocated to either the intervention group (Triamcinolone plus normal saline nasal irrigation) or the control group (Budesonide plus normal saline nasal irrigation) using block randomization with a 1:1 allocation ratio. The randomization unit is the individual participant. No stratified randomization will be used. The random allocation sequence will be generated using statistical software. Allocation concealment will be ensured by using sequentially numbered, opaque, sealed envelopes, which will be opened only after the participant has been enrolled in the study, Blinding description: This study will be conducted as a double-blind randomized clinical trial. Participants and outcome assessors will be blinded to the treatment allocation. The study medications will be prepared in identical containers with coded labels to ensure that the two interventions are indistinguishable in appearance, packaging, and method of administration. The randomization code will be kept by an independent researcher who is not involved in patient recruitment, outcome assessment, or data analysis. The allocation code will remain concealed until completion of data collection and primary statistical analysis, unless unblinding is required for patient safety. 3 Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Intervention 1: Intervention group: After endoscopic sinus surgery, participants receive nasal irrigation with a solution containing triamcinolone and 0.9% normal saline. The solution is prepared by dissolving 80 mg of triamcinolone (two 40-mg ampoules) in one liter of normal saline. Patients irrigate each nostril with 10–15 mL of the solution every 6 hours for three months. Intervention 2: Control group: After endoscopic sinus surgery, participants receive the standard treatment consisting of budesonide nasal spray (two sprays in each nostril every 12 hours, 64 micrograms per spray) together with nasal irrigation using 0.9% normal saline (10–15 mL per nostril every 6 hours) for three months. No - There is not a plan to make this available Justification or reason for not sharing IPD is Individual participant data (IPD) will not be shared due to confidentiality considerations, ethical requirements, and the limitations specified in the informed consent form. No further information is available.
public Amir Hossein Kiani
Shahid Shiroodi Street, Basij Square, Arak University of Medical Sciences
arak Iran (Islamic Republic of) 3819693345 0863214587 amirkiani9731@gmail.com Arak University of Medical Sciences scientific Amir Hossein Kiani
Shahid Shiroodi Street, Basij Square, Arak University of Medical Sciences
arak Iran (Islamic Republic of) 3819693345 +98 86 3278 5421 amirkiani9731@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Age 18 years or older Diagnosis of chronic rhinosinusitis with nasal polyps Undergoing endoscopic sinus surgery Candidate for postoperative nasal irrigation Willingness to participate and provision of written informed consent 18 years no limit Both Known hypersensitivity to triamcinolone or budesonide Pregnancy or breastfeeding Uncontrolled systemic disease interfering with study participation Refusal to participate before randomization Inability to perform nasal irrigation or complete follow-up J33 Nasal polyp Treatment - Drugs Treatment - Drugs Intervention group: After endoscopic sinus surgery, participants receive nasal irrigation with a solution containing triamcinolone and 0.9% normal saline. The solution is prepared by dissolving 80 mg of triamcinolone (two 40-mg ampoules) in one liter of normal saline. Patients irrigate each nostril with 10–15 mL of the solution every 6 hours for three months Control group: After endoscopic sinus surgery, participants receive the standard treatment consisting of budesonide nasal spray (two sprays in each nostril every 12 hours, 64 micrograms per spray) together with nasal irrigation using 0.9% normal saline (10–15 mL per nostril every 6 hours) for three months Change in the Sino-Nasal Outcome Test-22 questionnaire score. Timepoint: Before surgery, one month after surgery, and three months after surgery. Method of measurement: Measured using the standardized Sino-Nasal Outcome Test-22 questionnaire completed by the patient. Change in nasal endoscopic findings based on the Lund–Kennedy scoring system. Timepoint: Before surgery, one month after surgery, and three months after surgery. Method of measurement: Assessed by an otorhinolaryngologist using the standard Lund–Kennedy endoscopic scoring system. Arak University of Medical Sciences Approved 2025-05-21 Ethics Committee of Arak University of Medical Sciences Prophet Azam Campus, Km 5, Khomein Road, Arak, Markazi Province, Iran. Arak Markazi Iran (Islamic Republic of)