Investigating the effect of oral corticosteroids and pineapple extract and placebo on the treatment of postoperative ecchymosis and edema in patients who underwent rhinoplasty surgery.
Design
Patients will be randomly selected from among 60 patients referred for rhinoplasty surgery to Ayatollah Kashani Educational and Therapeutic Center and Al-Zahra Hospital of Isfahan University of Medical Sciences in 1402, randomly divided into appropriate groups treated with placebo, oral corticosteroid and Pineapple extract is divided. To collect the required data in this research, necessary information is collected from patients through direct observation of patients one day, one week later and 2 weeks after surgery. SPSS statistical software is used for data analysis. Statistical analyzes will include descriptive tests, analysis of variance (ANOVA).
Settings and conduct
The location of the study is Ayatollah Kashani Educational and Therapeutic Center and Al-Zahra Hospital of Isfahan University of Medical Sciences, where people are randomly divided into appropriate groups treated with placebo, oral coronet and pineapple extract. The patient does not know the type of treatment (placebo, corticosteroid or extract), but the doctor does.
Participants/Inclusion and exclusion criteria
Entry: Referrals for rhinoplasty surgery without underlying diseases (including heart, kidney, blood pressure and diabetes) and consent for the study. and exclusion criteria: patients with a history of previous rhinoplasty or septoplasty surgery
treating Ecchymosis and Edema After Rhinoplasty Surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240426061576N1
Registration date:2024-04-30, 1403/02/11
Registration timing:registered_while_recruiting
Last update:2024-04-30, 1403/02/11
Update count:0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
Samad Sarnameh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 515 8470
Email address
khaledian12@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of oral corticosteroids, and pineapple extract &palcebo in treating Ecchymosis and Edema After Rhinoplasty Surgery
Public title
Comparing the effectiveness of oral corticosteroids, and pineapple extract &palcebo in treating Ecchymosis and Edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Applicant for rhinoplasty surgery
Having no underlying disease (including heart, kidney, blood pressure and diabetes)
Exclusion criteria:
history of previous rhinoplasty or septoplasty surgery
Gastrointestinal complications or intolerance to medication (oral corticosteroid)
Age
To 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
hezar jarib-Postal code 7571145354
City
Isfahan
Province
Isfehan
Postal code
7571145354
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.MUI.MED.REC.1402.472
Health conditions studied
1
Description of health condition studied
rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
treating Ecchymosis and Edema
Timepoint
One day and one week later and 2 weeks after surgery
Method of measurement
Direct observation of patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention group: users of oral corticosteroids, second intervention group: users of pineapple extract, third intervention group: placebo users.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital and Kashani Hospital of Isfahan
Full name of responsible person
Seyed Mustafa Hashemi
Street address
Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
7571145354
Phone
+98 917 515 8470
Email
mostafa_hashemi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Mustafa Hashemi
Street address
Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
7571145354
Phone
+98 913 116 1027
Email
mostafa_hashemi@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Resident student
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Mustafa Hashemi
Position
Professor of Ear, Nose and Throat Department
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
7571145354
Phone
+98 913 116 1027
Email
mostafa_hashemi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samad Sarnameh
Position
resident ENT
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar jarib, Koye Emam
City
Isfahan
Province
Isfehan
Postal code
7571145354
Phone
+98 917 515 8470
Email
khaledian12@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samad Sarnameh
Position
Resident ENT
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar jarib, koye Emam
City
Isfahan
Province
Isfehan
Postal code
7571145354
Phone
+98 917 515 8470
Email
khaledian12@ut.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Considering that it is a thesis, the abstract should be printed
When the data will become available and for how long
One year after publication
To whom data/document is available
Ear, throat and nose researchers
Under which criteria data/document could be used
For scientific study
From where data/document is obtainable
Resident
What processes are involved for a request to access data/document