Platelet-rich plasma efficacy in improving olfactory odor in patients with sinusoidal polyposis
Design
Clinical trial, randomized block allocation method by quota method to two parallel groups of 27 patients, Double-blind
Settings and conduct
Sampling was available type among those who referred to the ENT clinic of Taleghani Hospital in Tehran. Platelet-rich plasma was injected into the intervention group after endoscopic sinus surgery in the operating room and under general anesthesia.The patients were unaware of the type of intervention performed during anesthesia and the technician who evaluates the outcome was not present during the surgical procedure.
Participants/Inclusion and exclusion criteria
Study entry requirements:
_15 to 50 years old
_Having chronic sinusitis with polyps
_Anosmia or Hyposmia confirmed by olfactory testing
_Anosmic duration less than 2 years
Conditions for not entering the study:
_History of head injuries
_History of previous sinus surgery
_Smoking
_Congenital anosmia
_Systemic diseases
Intervention groups
Patients with polyposis with hyposmia were treated with oral corticosteroids for 5 days.Patients were then divided into two groups: intervention and control. In each group, the quota was based on the severity of the polyposis. Patients in both groups underwent functional endoscopic sinus surgery by only one specific ENT specialist. At this stage, in the intervention group, platelet-rich plasma and In the control group, the Normal saline serum was injected into the patient's olfactory mucosa inside the operating room and during general anesthesia. Smell test score in all patients before any intervention and endoscopic sinus surgery and 3 months after surgery with Smell diagnosis test was performed by a technician and the results were recorded. Then the scores of the Smell test were compared in both groups.
Main outcome variables
Smell test score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200211046464N1
Registration date:2020-05-04, 1399/02/15
Registration timing:retrospective
Last update:2020-05-04, 1399/02/15
Update count:0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Mehdi Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4483 3279
Email address
mohammady_md@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2019-09-23, 1398/07/01
Scientific title
Evaluation the effectiveness of platelet-rich plasma in smell Improvement of Patients with nasal polyposis due to chronic sinusitis
Public title
Effect of PRP in treatment of anosmia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 15 and 50 years
Having chronic sinusitis with polyps
Anosmia lasts less than 2 years
Existence of anosmia confirmed by olfactory diagnosis test
Exclusion criteria:
Suffering from systemic diseases such as diabetes mellitus, Parkinson's and Alzheimer's
smoking
Head injury history
Previous surgical history of paranasal sinuses
Congenital anosmia
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
24
Actual sample size reached:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Block Random assignment
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients are unaware of the type of intervention performed during general anesthesia and the technician who evaluates the outcome is not present during the surgical procedure. Surgeon in charge of injection.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National committee for Ethics in Biomedical Research
Street address
floor 2., No. 11, Mohammadi Rd., East Kourosh St., North Janat Abad Blvd
City
Tehran
Province
Tehran
Postal code
1477835814
Approval date
2019-04-23, 1398/02/03
Ethics committee reference number
IR.SBMU.MSP.REC.1398.011
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
Anosmia
ICD-10 code
R43.0
ICD-10 code description
Anosmia
Primary outcomes
1
Description
Olfactory score less than 6 in the Iranian Smell Identification Test
Timepoint
Measurement of olfactory score at the beginning of the study (before the intervention), After receiving oral treatment and 3 months after surgery and injection of platelet-rich plasma
Method of measurement
Iranian Smell Identification Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in both groups underwent sinus endoscopic surgery by only one specific ENT specialist. At this stage, in the intervention group, a platelet-rich plasma was injected into the patient's nose inside the operating room and during general anesthesia. To do this, platelet-rich plasma was injected with a 1 cc syringe in the olfactory area within 1 cm2 with the help of a nasal endoscope and by the same surgeon from specific ENT specialists. The whole process of preparing platelet-rich plasma was performed in the sports medicine group under the supervision of the sports medicine professor and using Arjangian platelet-rich plasma kits. The temperature during these steps to prevent plaque clots was 21-24. C.
Category
Treatment - Other
2
Description
Control group:After Functional endoscopic sinus surgery, in the control group, instead of platelet-rich plasma, normal saline serum was injected into the patient's olfactory area with the same amount and under the same conditions. The injector was also unaware of the group of patients and the injected substance.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Mehdi Mohammadi
Street address
ENT Department., Taleghani Hospital., Next to Shahid Beheshti University of Medical Sciences., Shahid Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Fax
+98 21 2243 2570
Email
Taleghanihospital@sbmu.ac.ir
Web page address
http://taleghani.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Deputy of Research and Technology., 5th Floor., Headquarters Building 2., Shahid Beheshti University of Medical Sciences and Health Services., Next to Taleghani Hospital., Shahid Abbas Aarabi St., (Parvaneh)., Shahid Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 9780
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Web page address
https://retech.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
Mehdi Mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
floor 2., No. 11, Mohammadi Rd., East Kourosh St., North Janat Abad Blvd
City
Tehran
Province
Tehran
Postal code
1477835814
Phone
+98 21 4483 3279
Email
Dr.md.mohammadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Goljanian Tabrizi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Rhinology
Street address
ENT Department., Taleghani Hospital., Next to Shahid Beheshti University of Medical Sciences., Shahid Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Fax
+98 21 2243 2570
Email
ali.goljanian@gmail.com
Web page address
http://taleghani.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobeh Asadi Amiri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
ENT Department., Taleghani Hospital., Next to Shahid Beheshti University of Medical Sciences., Shahid Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
Mahboobeh_farvardin@yahoo.com
Web page address
http://taleghani.sbmu.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome after not identifying individuals
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Scientific research in academic institutions
From where data/document is obtainable
Ali Goljanian Tabrizi; Ali.goljanian@gmail.com
Mahboobeh Asadi Amiri; Mahboobeh_farvardin@yahoo.com
What processes are involved for a request to access data/document
State the name, academic or professional rank, the applicant center and the reason for the application in your email. Files and documents will be sent about 1 month after the request is processed.