A Comparative Evaluation of the Effects of Betamethasone Drops versus Fluticasone Nasal Spray on Chronic Rhinosinusitis Following Endoscopic Sinus Surgery: A Randomized Controlled Trial

Efficacy of Betamethasone Nasal Drops in Post-Sinus Surgery Patients with Chronic Rhinosinusitis and Nasal Polyps: A Controlled Study"

This clinical trial will include an intervention group and a control group, with a sample size of 80 participants in each group. Blinding: Triple-blind. Randomization: The random allocation sequence with unique codes will be generated using the Sealedenvelope website

All patients will have a preoperative CT scan (Lund–Mackay score), SNOT-22 questionnaire, and Lund–Kennedy endoscopic assessment. CBC, glucose, cortisol, ACTH, and IgE will be measured before surgery and at 1, 3, and 6 months. Participants will be recruited at Amir-al-Momenin Educational and Therapeutic Center, Rasht, Iran, during 2025–2026.

Inclusion Criteria: Patients aged 18 to 65 years, diagnosed with chronic rhinosinusitis with nasal polyps, who are candidates for endoscopic sinus surgery due to lack of response to maximal medical therapy. Exclusion Criteria: History of prior endoscopic sinus surgery Recent smoking Systemic diseases Hypothalamic-pituitary-adrenal axis dysfunction Central compartment disease Chronic rhinosinusitis without nasal polyps Presence of mucocele History of skull base fractures Patients with glaucoma or increased intracranial pressure

Intervention groups:The patient received intranasal betamethasone drops together with saline spray as placebo, and intranasal fluticasone spray Control group: The patient received intranasal fluticasone , and saline drops

The mean scores of the Lund–Mackay, Lund–Kennedy, and SNOT-22, as well as serum levels of cortisol, ACTH, IgE, WBC, lymphocytes, neutrophils, and eosinophils, will be determined and compared between the study groups at baseline

Method used for generating the randomization sequence, including the software or website used: To generate a randomization sequence with a unique code, the Sealed Envelope website was used . All eligible patients will be allocated to groups A and B in equal proportions (1:1) using stratified block randomization with block sizes of fou

Participants: Patients will be unaware of which treatment they are receiving (betamethasone drops or fluticasone spray). To maintain blinding, identical-looking containers will be used for both medications. Healthcare Providers/Investigators: Physicians and nurses administering the treatments and monitoring patients will also be blinded to the assigned intervention. This ensures that their assessments and interactions are not influenced by knowledge of the treatment. Outcome Assessors/Analysts: Individuals evaluating clinical outcomes, performing endoscopic scoring, and analyzing the data will remain blinded to group allocation until the completion of data analysis. Randomization codes will be securely held by a third-party (e.g., a statistician or independent coordinator) who will not participate in patient care or outcome assessment. Codes will be revealed only after the final analysis is completed

Data will be shared comprehensively and will include all the variables mentioned above, not being limited to only the primary outcomes. Following the removal of all direct identifiers (such as name, medical record number, national identification code) and the application of ethical considerations, these data will be made available to researchers for legitimate research purposes

The data and document access period will begin from the project's completion and after the initial results are published in a scientific article. This access will be available for a minimum of 5 years after the project's end date.

Access to the de-identified data from this research will be provided to researchers and investigators affiliated with academic institutions, scientific research centers, or healthcare-therapeutic organizations. Requests for access must have a valid scientific justification and clear research objectives, and must be approved by an independent ethics review committee. This access does not include researchers working in industry (pharmaceutical or medical device industries), except within the framework of approved scientific collaborations with the university and with full adherence to ethical considerations and confidentiality preservation

The data and documents from this research will be accessible solely for research and academic purposes, including conducting secondary studies, meta-analyses, validation of findings, and educational objectives (with proper citation). Applicants must submit a written request along with a detailed research proposal and provide a certificate of approval from the ethics committee of their affiliated institution. Commercial use of the data in any form is not permitted, and the applicant is required to sign an agreement ensuring confidentiality, citing the original source in all publications, refraining from re-identifying participants, submitting draft manuscripts to the principal investigator prior to publication, not transferring data to third parties, and deleting the data upon project completion. All requests will be evaluated and subject to final decision by the Research Oversight Committee.

To access the data and documents from this research, applicants can submit their requests in order of priority via email to akbarpour_malihe@yahoo.com with the subject line "Request for Access to Chronic Rhinosinusitis Research Data" addressed to Dr. Malihe Akbarpour (Principal Investigator). If a telephone call is necessary, contact can be made at 09001311808 from Saturday to Wednesday between 10:00 and 14:00. Additionally, written requests can be sent by mail to the following address: Guilan Province, Rasht City, Amir al-Momenin Hospital, Otorhinolaryngology Research Center, Postal Code: [Exact postal code to be specified according to hospital protocol], Attn: Dr. Malihe Akbarpour. It should be noted that all requests must include a detailed research proposal, ethics committee approval, and complete contact information, with email communications receiving priority processing. All received requests will be reviewed and evaluated by the principal investigator and the Research Oversight Committee at Guilan University of Medical Sciences.

The process for requesting access to the data from this research is a multi-stage procedure that typically takes 5 to 8 business weeks to complete. After the applicant submits a complete request (including the research proposal, ethics approval, and contact information), an initial review is conducted by the principal investigator. If necessary, supplementary correspondence will take place and a Data Use Agreement will be sent (1 to 2 weeks). The request is then referred to the Research Oversight Committee of Guilan University of Medical Sciences for scientific and ethical evaluation (2 to 4 weeks). Following final approval by the committee (1 week), if approved, the de-identified data will be delivered in processable file formats through secure methods (1 week). It should be noted that this timeframe may vary slightly depending on the volume of requests and the committee's meeting schedule. The status of the request can be followed up via email at akbarpour_malihe@yahoo.com.