Evaluation the effect of fibrin glue autolog on amandation tissues and polyps relapse on sinusoidal patients after (Functional Endoscopic Sinus Surgery) FESS
Design
Clinical trial with control group, parallel groups with One-blind randomized trial, phase 3-2 on 32 patients and andomized with table numbers
Settings and conduct
This study will be performed on patients referred to the ENT department of subspecialty clinic of Ghaem Hospital in Mashhad, who have bilateral sinus nasal polyps and FESS candidates surgery. The study is monocentric and single-blind while the patients will not be aware of the allocation which type of solution to each side of the nose.
Participants/Inclusion and exclusion criteria
Bilateral sinus nasal polyps and the same drug treatment and lack of immunological diseases prone to improper wound healing, no history of abnormal bleeding or thrombocytopenia
Intervention groups
During this study, after endoscopic sinus surgery and removal of bilateral polyps, on the surgical bed one cc of normal saline solution is poured in a side of the patient's nose as the control group and on the other side of the same patient's nose as the intervention group One cc of fibrin glue solution prepared from the individual's own serum will be poured into opened sinuses by syringe under the endoscope.
Main outcome variables
Improvement of Sinonazal Polyposis Symptoms after FESS surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180217038763N4
Registration date:2022-04-25, 1401/02/05
Registration timing:prospective
Last update:2022-04-25, 1401/02/05
Update count:0
Registration date
2022-04-25, 1401/02/05
Registrant information
Name
mehdi bakhshaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3492
Email address
mehbakhsh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-07-01, 1401/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fibrin glue autolog on amandation tissues and relapse polyps on sinusoidal patients after (Functional Endoscopic Sinus Surgery) FESS
Public title
Evaluation of the effect of fibrin coagulation solution on improving nasal polyps
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bilateral nasal sinus polyp
Identical drug treatment in patients
Satisfaction to enter the study
Exclusion criteria:
Presence of enterocanal polyps
Unilateral polyp
Immunological diseases prone to improper wound healing
History of abnormal bleeding or thrombocytopenia
History of previous sinus surgery
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, a list of patients who met the inclusion criteria is prepared and 32 patients will be selected using a random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study would be performed with the complete consent of the patients while the patient does not know which side of the nose is treating with control solution and which side of the nose is getting intervention solution.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Approval date
2022-04-09, 1401/01/20
Ethics committee reference number
IR.MUMS.REC.1401.017
Health conditions studied
1
Description of health condition studied
Sinonazal polyps
ICD-10 code
J33
ICD-10 code description
Nasal polyp
Primary outcomes
1
Description
Improvement of Sinonazal Polyposis Symptoms
Timepoint
One week, one month and three months after surgery
Method of measurement
Lund-kennedy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: During this study, after sinus endoscopic surgery and removal of bilateral polyps, the surgical environment on one side of the patient's nose one cc of normal saline solution is poured inside the nose and the open sinuses by syringe under endoscopic vision.
Category
Placebo
2
Description
Intervention group: During this study, after endoscopic sinus surgery and removal of bilateral polyps, the surgical environment on the other side of the same patient's nose received one cc of fibrin coagulation solution prepared from the individual's own serum is poured inside the nose and sinuses opened by a syringe under endoscopic vision.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mehdi Bakhshaee
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
bakhshaeem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mehdi Bakhshaee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
bakhshaeem@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehdi Bakhshaee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
Mehbakhsh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehdi Bakhshaee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
bakhshaeem@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available