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Effects of Combined serum and fluticasone in chronic rhinosinusitis with polyposis in post op FESS patients

Protocol summary

Study aim
Effect of Combined serum (betamethasone, dexamethasone, bromhexine N/S) with fluticasone spray and N/S on 200 postoperative CRS patients with polyposis after FESS surgery
Design
controlled, single-blind, randomized, phase 2 clinical trial on 200 patients. The rand function of Excel software was used.
Settings and conduct
In this study, all patients referred to the clinic of Masih-Daneshvari Hospital with the diagnosis of chronic rhinosinusitis and polyposis will be divided into two randomized groups. None of the patients know the group they will be in, but the research team will be aware of it and the type of treatment. Patients will come back to the clinic one week after the surgery and according to the type of their group, they will receive the relevant interventional treatment for 3 weeks. Also, the Persian version of the SNOT-22 questionnaire, whose validity and reliability have been confirmed, will be used before and after the treatment. A questionnaire that measures the quality of life related to nose and sinus diseases with total scores between 0 and 110 and each item is graded on 6 levels (0-5).
Participants/Inclusion and exclusion criteria
Including criteria: Patients aged 18 to 70 with chronic rhinosinusitis who undergo endoscopic surgery due to nasal polyposis. Excluding criteria: Asthma, Severe systemic problems such as Heart Failure and Diabetes, Pregnancy, Cystic Fibrosis, Malignancies
Intervention groups
In the first group, at first, 10CC of mixed serum (one ampoule of betamethasone, dexamethasone, and bromhexine dissolved in a liter of normal saline washing serum) was poured into each nostril, then repeated every 12 hours. In the second group, at first 10CC normal saline serum was poured into each nostril, then fluticasone sprays 1 puff every 12 hours will be used.
Main outcome variables
Age, gender, endoscopic status, quality of life; before and after treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191009045040N1
Registration date: 2022-12-17, 1401/09/26
Registration timing: prospective

Last update: 2022-12-17, 1401/09/26
Update count: 0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Seyed amir ali Safavi naini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 2955
Email address
md.safavi.naini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
2022-12-22, 1401/10/01
Actual recruitment end date
2023-01-21, 1401/11/01
Trial completion date
2023-01-21, 1401/11/01
Scientific title
Effects of Combined serum and fluticasone in chronic rhinosinusitis with polyposis in post op FESS patients
Public title
Effects of Combined serum and fluticasone in chronic rhinosinusitis with polyposis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between the ages of 18 and 50, with chronic rhinosinusitis with polyposis
Exclusion criteria:
without mucociliary disease, heart disease, diabetes, and no history of malignancy
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Masih Daneshvari of Shaheed Beheshti University of Medical Sciences
Street address
Daranad st.
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2022-04-25, 1401/02/05
Ethics committee reference number
IR.SBMU.NRITLD.REC.1401.005

Health conditions studied

1

Description of health condition studied
Nasal polyp
ICD-10 code
J33
ICD-10 code description
Nasal polyp

2

Description of health condition studied
Chronic sinusitis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis

Primary outcomes

1

Description
Symptoms of rhinosinusitis include; Sneezing, runny nose, coughing, post-nasal discharge, thick nasal discharge, dizziness, ear fullness, pain and pressure in the ears, pain and pressure in the face, lack of taste or smell, nasal obstruction/congestion.
Timepoint
21 days after treatment
Method of measurement
SNOT22 score

Secondary outcomes

empty

Intervention groups

1

Description
BD nasal irrigation with N/S& DeXMT (16mg) & BeTMT(8mg) & BrMHX (4mg)
Category
Treatment - Drugs

2

Description
Control group: Fluticasone spray +BD nasal irrigation with N/S
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari hospital
Full name of responsible person
Amirali Safavi
Street address
Darabad st.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 912 838 4529
Email
Md.amirali.safavi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. afshin Zarghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway, Velenjak.
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9780
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Safavi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Darabad st.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2627 1000
Email
md.safavi.naini@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Safavi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Darabd st.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 1000
Email
Md.safavi.naini@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Safavi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Darabad st.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2627 1000
Email
Md.safavi.naini@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Part of the data, such as information related to the main outcome or similar, can be shared.
When the data will become available and for how long
1 year after publication
To whom data/document is available
Dr. Jahangir Ghorbani Dr. Ali Safavi
Under which criteria data/document could be used
Unknown
From where data/document is obtainable
Dr. Ali Safavi
What processes are involved for a request to access data/document
Unknown
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