Comparison of results of frontal sinus surgery with direct injection of Corticosteroid (Triamcinolone) and foam gel containing Corticosteroid (Triamcinolone)
Comparison of results of frontal sinus surgery with direct injection of Corticosteroid (Triamcinolone) and foam gel containing Corticosteroid (Triamcinolone)
Design
The study is a randomized, clinical trial consisting of 36 patients in 2 parallel groups with a double-blind design
Settings and conduct
Tabriz Sina hospital, endoscopic sinus surgery
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Age of 18 to 65 years, Chronic rhinosinusitis as defined by the American Academy of Otolaryngology, patients have proved rhinosinusitis by CT-scan.Exclusion criteria include:Patients who are taking daily corticosteroid drugs, Pregnant patient, Existence of any polyp in the nasal cavity, Patient unwillingness to continue participating in the clinical trial
Intervention groups
One group of patients with chronic rhinosinusitis with bilateral polyposis received Triamcinolone impregnated gel foam as a nasal dressing and the other group received a topical injection of Triamcinolone
Main outcome variables
The rate of satisfaction, Inflammation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211218053446N1
Registration date:2021-12-28, 1400/10/07
Registration timing:prospective
Last update:2021-12-28, 1400/10/07
Update count:0
Registration date
2021-12-28, 1400/10/07
Registrant information
Name
Saleh jalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
mehr_mousavi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of results of frontal sinus surgery with direct injection of Corticosteroid (Triamcinolone) and foam gel containing Corticosteroid (Triamcinolone)
Public title
Triamcinolone injection in frontal sinus surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Chronic rhinosinusitis as defined by the American Academy of Otolaryngology
patients have proved rhinosinusitis by CT-scan
Exclusion criteria:
Patients who are taking daily corticosteroid drugs
Pregnant patient
Existence of any polyp in the nasal cavity
Patient unwillingness to continue participating in clinical trial
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, individuals were assigned to two groups using the permutation block method. In this method, a represents the individual receiving the foam gel containing Triamcinolone and B represents the individual in the topical Triamcinolone group. Considering the quadruple block; they were classified into AABB, ABAB, ABBA, BAAB BBAA, and BABA permutations, and by random selection from permutation patients were classified.
Blinding (investigator's opinion)
Double blinded
Blinding description
The treatment assessor and the statistical analyst will not be aware of the allocation of intervention until the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Medical School
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2020-10-26, 1399/08/05
Ethics committee reference number
IR.TBZMED.REC.1399.756
Health conditions studied
1
Description of health condition studied
Chronic rhinosinusitis
ICD-10 code
J32.9
ICD-10 code description
Chronic sinusitis, unspecified
Primary outcomes
1
Description
Inflammation
Timepoint
1 month, 3 months, 6 months
Method of measurement
Physical Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Triamcinolone impregnated gel foam nasal dressing
Category
Treatment - Drugs
2
Description
Control group: Topical injection of Triamcinolone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Sina Hospital
Full name of responsible person
Dr Mehrnoosh Mousaviagdas
Street address
Tabriz Sina Hospital, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Email
mehr_mousavi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Masood Naderpour
Street address
Department of Otolaryngology, Imam Reza Hospital, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
info@imamreza.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
10
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoush Mousavi Aghdas
Position
Otolaryngorhinologist
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Tabriz University of Medical Sciences, Daneshgah street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
mehr_mousavi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehrnoosh Mousaviagdas
Position
Otolaryngorhinologist
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Tabriz University of Medical Sciences, Daneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7056
Email
mehr_mousavi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
saleh jalali
Position
Resident of ENT
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
ENT ward, Emam Reza Hospital, Gholghasht Street, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
shayan.jj1370@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A portion of the data that represents the final outcome
When the data will become available and for how long
Access will be 6 months after the results are printed
To whom data/document is available
Otolaryngology specialists in coordination with the presenter
Under which criteria data/document could be used
The use of data to improve patients' treatment processes is safe
From where data/document is obtainable
Person responsible for updating study information
What processes are involved for a request to access data/document
Requesting data and study documents will be done by correspondence with the person responsible for updating the study information