Pre and post operation evaluation of laryngeal stroboscopic characteristic in patients with bilateral nasal polyposis who undergo endoscopic sinus surgery in Amir alam hospital in 2013
Goal: pre and post operation evaluation of laryngeal stroboscopic characteristic in patients with bilateral nasal polyposis.
Design: this is a clinical trial study;
patients with bilateral nasal polyposis who are candidate for sinus surgery, undergo stroboscopic laryngeal evaluation before and 3 months after surgery.
Inclusion criterion: all patients with bilateral nasal polyposis who undergo endoscopic sinus surgery.
Exclusion criteria: 1. history of sinus or laryngeal surgery;2. history of any disease that prolonged corticosteroid therapy is needed and 3. history of any disease that preclude surgery.
Intervention: with endoscopic approach nasal polypectomy and preservation of normal mucosa are performed.
Variables: mucosal color, mucosal edema, mucosal lesion,vocal cord movement, mucosal wave is evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040612907N1
Registration date:2013-04-17, 1392/01/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-17, 1392/01/28
Registrant information
Name
Akbar Bayat
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 0740
Email address
bayata@irimc.org
Recruitment status
Recruitment complete
Funding source
wise chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pre and post operation evaluation of laryngeal stroboscopic characteristic in patients with bilateral nasal polyposis who undergo endoscopic sinus surgery in Amir alam hospital in 2013
Public title
Pre and post operation evaluation of laryngeal stroboscopic characteristic in bilateral nasal polyposis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: all patients with bilateral nasal polyposis who undergo endoscopic sinus surgery
Exclusion criteria: 1. history of sinus or laryngeal surgery;2. history of any disease that prolonged corticosteroid therapy is needed and 3. history of any disease that preclude surgery.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran University of Medical Sciences, Keshavarz Blv.
City
Tehran
Postal code
Approval date
2013-02-25, 1391/12/07
Ethics committee reference number
79176-18271-48-04-91
Health conditions studied
1
Description of health condition studied
Nasal polyposis
ICD-10 code
J33.9
ICD-10 code description
Nasal polyp, unspecified
Primary outcomes
1
Description
Laryngeal characteristic
Timepoint
Preoperation and 3 months post operation
Method of measurement
Laryngeal stroboscopic evaluation
Secondary outcomes
1
Description
Improvement of laryngeal changes
Timepoint
Three months post operation
Method of measurement
Laryngeal stroboscopic evaluation
Intervention groups
1
Description
Endoscopic nasal polypectomy with preservation of normal mucosa and improvement of nasal obstruction.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Alam hospital
Full name of responsible person
Dr. Akbar Bayat
Street address
Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellorfor research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotohi
Street address
Ghods ST, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellorfor research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of ENT, Amir alam hospital
Full name of responsible person
Dr. Akbar Bayat
Position
flowship or head and neck surgery
Other areas of specialty/work
Street address
fift ST, bistochahar metry Blvd
City
Tehran
Postal code
1997758843
Phone
+98 21 2236 1104
Fax
Email
bayata@irimc.org
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of ENT, Amir Alam hospital
Full name of responsible person
Dr. Akbar Bayat
Position
flowship of head and neck surgery
Other areas of specialty/work
Street address
fift ST, bistochahar metry Blvd
City
Tehran
Postal code
1997758843
Phone
+98 21 2236 1104
Fax
Email
bayata@irimc.org
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of ENT, Amir alam hospital
Full name of responsible person
Dr. Akbar Bayat
Position
flowship of head and neck surgery
Other areas of specialty/work
Street address
fift ST, bistochahar metry Blvd
City
Tehran
Postal code
1997758843
Phone
+212 2361104
Fax
Email
bayata@irimc.org
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)