Protocol summary

Summary
The purpose of this study is to assess the efficacy of adeotonsillectomy comparing with adenoidectomy for treatment of symptoms and signs caused by chronic sinusitis.sixty-under the age of 14 years- subjects with chronic sinusitis were recruited from patients referred to otolaryngology clinic,Besat hospital Hamedan University of Medical Science.symptoms and signs of this patient include purulent discharge,facial pain, post nasal purulent discharge,cough,halitosis and bilateral maxillary mucosal thickening in water's view radiography.symptoms and signs of patient did not improved with medical therapy(oral antibiotic & anti allergy for at least 4 weeks).the baseline subject symtoms perception was assessed using visual analogue scale before the intervention .children randomly divided into 2 groups and in one group adenoidectomy and in another adenotonsillectomy was performed. all children discharge from hospital in second day after surgery. all children had the same antibiotics and nutritoin and nursing a week after surgery. in twenty eight day after surgery waters view radiography is performed and clinical signs and symptoms by person is informed of the child's medical & surgical history will be recorded in check list. finally the efficacy of adenotonsillectomy & adenoidectomy by comparig the check lists is evaluated

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012081810409N3
Registration date: 2012-09-07, 1391/06/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-09-07, 1391/06/17
Registrant information
Name
Mohammad Hassan Ahmadi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 9042
Email address
m.ahmadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Hamedan university of medical Sciences and health services
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of Adenidectomy versus Adenotonsillectomy on changing in symptoms in pediatric patients with chronic rhinosinositis
Public title
Comparision of Adenidectomy versus Adenotonsillectomy on changing in symptoms in patients less than 14 years old with chronic rhinosinositis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusin criteria: children -under the age of 14 years- subjects with chronic sinusitis were recruited from patients referred to otolaryngology clinic,Besat hospital Hamedan University of Medical Science.symptoms and signs of this patient include purulent discharge,facial pain, post nasal purulent discharge,cough,halitosis and bilateral maxillary mucosal thickening in water's view radiography.symptoms and signs of patient did not improved with medical therapy(oral antibiotic & anti allergy for at least 4 weeks). exclusion critera: 1-children with chronic sinusitis with tonsil size and grade have less than 2-tonils occupy less than 25% of their oropharyngeal space - 2-patient with systemic diseases such as diabetes,anemia,immunodificiency,nasal polyposis ,...
Age
To 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan University of Meical Science
Street address
Fahmide str, Hamedan
City
Hamedan
Postal code
Approval date
2012-07-03, 1391/04/13
Ethics committee reference number
16/35/9/1217/پ/د

Health conditions studied

1

Description of health condition studied
Chronic Rhinosinusitis
ICD-10 code
J32.9
ICD-10 code description
Chronic sinusitis, unspecified

Primary outcomes

1

Description
NasalL Obstruction/Blocage
Timepoint
Before surgery-one month after surgery
Method of measurement
visual analogue scale

2

Description
halitosis
Timepoint
Before surgery-one month after surgery
Method of measurement
visual analogue scale

3

Description
facial pain/pressure
Timepoint
Before surgery-one month after surgery
Method of measurement
visual analogue scale

4

Description
nasal discharge
Timepoint
Before surgery-one month after surgery
Method of measurement
visual analogue scale

5

Description
posterior drange
Timepoint
Before surgery-one month after surgery
Method of measurement
visual analogue scale

6

Description
cough
Timepoint
Before surgery-one month after surgery
Method of measurement
visual analogue scale

7

Description
waters view radiography
Timepoint
Before surgery-one month after surgery
Method of measurement
Questionare

Secondary outcomes

empty

Intervention groups

1

Description
adenoidectomy surgery
Category
Treatment - Surgery

2

Description
adenotonsillectomy surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
DR Mohammad Ahmadi-assistant of otolaryngology
Street address
Motahhari ave, Hamedan
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Meical Science
Full name of responsible person
Dr Hoseyn Emadmomtaz
Street address
Fahmide str, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Meical Science
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
Hamedan University of Meical Science
Full name of responsible person
Dr Mohammad Ahmadi
Position
ASSISTANT OF OTOLARYNGOLOGY
Other areas of specialty/work
Street address
no 156, Daneshgah ave, Hamedan
City
Hamedan
Postal code
65177-68866
Phone
+98 81 1827 9042
Fax
+98 81 1827 9108
Email
M.AHMADI@UMSHA.AC.IR
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Meical Science
Full name of responsible person
Dr Fatollah Behnood
Position
Associate Professor of otolaryngology
Other areas of specialty/work
Street address
Besat hospital, Motahari ave, Hamedan
City
Hamedan
Postal code
65177-68866
Phone
+98 81 1264 0048
Fax
Email
M.AHMADI@UMSHA.AC.IR
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mohammad Ahmadi
Position
ASSISTANT OF OTOLARYNGOLOGY
Other areas of specialty/work
Street address
no156, Daneshgah ave, Hamedan
City
Hamedan
Postal code
65177-68866
Phone
+98 81 1827 9042
Fax
+98 81 1827 9108
Email
M.AHMADI@UMSHA.AC.IR
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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