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
To compare the effectiveness of nasal irrigation with triamcinolone plus normal saline versus budesonide nasal spray plus normal saline in reducing postoperative complications in patients with chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery.
Design
A randomized, double blind, parallel group clinical trial including 84 patients. Participants will be allocated using permuted block randomization
Settings and conduct
The study will be conducted at Ayatollah Khansari Hospital and Imam Reza Clinic in Arak, Iran. After surgery, participants will be randomly assigned to one of two groups. Patients, outcome assessors, and data analysts will remain blinded to treatment allocation
Participants/Inclusion and exclusion criteria
Patients with chronic rhinosinusitis with nasal polyps undergoing endoscopic sinus surgery. Inclusion criteria: confirmed diagnosis based on clinical findings and computed tomography scan, written informed consent. Exclusion criteria: anatomical sinus abnormalities or unwillingness to continue participation
Intervention groups
Group one receives budesonide nasal spray plus normal saline irrigation. Group two receives nasal irrigation with triamcinolone mixed with normal saline
Main outcome variables
Sino Nasal Outcome Test 22 score; Lund Kennedy endoscopic score; Lund Mackay computed tomography score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260218068916N1
Registration date:2026-07-03, 1405/04/12
Registration timing:prospective
Last update:2026-07-03, 1405/04/12
Update count:0
Registration date
2026-07-03, 1405/04/12
Registrant information
Name
amirhossein kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2605
Email address
amirkiani9731@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-22, 1405/04/31
Expected recruitment end date
2027-04-18, 1406/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Comparison of Triamcinolone and Budesonide Nasal Irrigation after Endoscopic Sinus Surgery in Patients with Chronic Rhinosinusitis with Nasal Polyps
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Prophet Azam Campus, Km 5, Khomein Road, Arak, Markazi Province, Iran.
City
Arak
Province
Markazi
Postal code
36661254687
Approval date
2025-05-21, 1404/02/31
Ethics committee reference number
IR.ARAKMU.REC.1404.300
Health conditions studied
1
Description of health condition studied
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
ICD-10 code
J33
ICD-10 code description
Nasal polyp
Primary outcomes
1
Description
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.
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital
Full name of responsible person
Benyamin Rahmaty
Street address
Department of Otorhinolaryngology, Ayatollah Khansari Hospital, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
6632145687
Phone
+98 86 3278 6545
Email
benyamin.rahmaty@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Arak University of Medical Sciences
Street address
Arak University of Medical Sciences Shahid Shiroodi Street, Basij Square, Arak, Markazi Province
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3278 6521
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Amir Hossein Kiani
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shahid Shiroodi Street, Basij Square, Arak University of Medical Sciences
City
arak
Province
Markazi
Postal code
3819693345
Phone
0863214587
Email
amirkiani9731@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Amir Hossein Kiani
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Shiroodi Street, Basij Square, Arak University of Medical Sciences
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3278 5421
Email
amirkiani9731@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Amir Hossein Kiani
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shahid Shiroodi Street, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
1662569814
Phone
+98 86 3278 6514
Email
amirkiani9731@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
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.