This clinical trial will be conducted to evaluate the role of adeno-tonsillectomy on treatment of children under 14 years old who suffered from chronic rhino-sinusitis with documented clinical and radiological signs and symptoms. Inclusion criteria are all the patients who are candidate for adeno-tonsillectomy and suffered from chronic sinusitis and the patients having contraindication for adeno-tonsillectomy, or the conditions such as diabetes, anemia and nasal polyp will exclude from the study. Forty children will be enrolled in the study. Intervention of this trial is adeno-tonsillectomy. The main outcomes will be assessed two weeks after adeno-tonsillectomy and are: the result from plain radiography (water's view) and clinical signs. The outcomes will be compared in study groups.
General information
Acronym
Adeno tonsillectomy on chronic rhinosinusitis
IRCT registration information
IRCT registration number:IRCT138811063187N1
Registration date:2011-05-04, 1390/02/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-04, 1390/02/14
Registrant information
Name
Fatholah Behnoud
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81126440064
Email address
behnoud@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of children with chronic rhinosinositis after adeno tonsillectomy
Public title
Evaluation of children with chronic rhinosinositis after adeno tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under 14 candidated for adeno tonsillectomy and suffered from chronic sinusitis.
Exclusion criteria:
Having contrindication for adeno tonsillectomy, the conditions such as diabetes, anemia and nasal polyp.
Age
To 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Besat Hospital
City
Hamedan
Postal code
6514845411
Approval date
2009-09-23, 1388/07/01
Ethics committee reference number
p/16/35/1/361111
Health conditions studied
1
Description of health condition studied
Chronic sinusitis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis
Primary outcomes
1
Description
X ray result
Timepoint
Before intervention
Method of measurement
Sinus X-ray changes
Secondary outcomes
1
Description
Halitosis
Timepoint
2 weeks
Method of measurement
Cinical examination
2
Description
Rhinorrea
Timepoint
2 weeks
Method of measurement
Clinical examination
3
Description
Chronic cough
Timepoint
2 weeks
Method of measurement
Clinical examination
Intervention groups
1
Description
Adeno-tonsillectomy surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Behnoud
Street address
Besat Hospital
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ghalehia
Street address
Hamedan University
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Hamedan 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
Hamedan University of Medical Science
Full name of responsible person
Fatholah Behnoud
Position
Associated Professor
Other areas of specialty/work
Street address
Besat Hospital
City
Hamedan
Postal code
6514845411
Phone
+98 81 1823 0461
Fax
Email
behnoud@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Fatholah Behnoud
Position
Associated Professor
Other areas of specialty/work
Street address
Besat Hospital Hamedan
City
Hamedan
Postal code
6514845411
Phone
+98 81 1823 0461
Fax
Email
behnoud@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. Fatholah Behnoud
Position
Associated Professor
Other areas of specialty/work
Street address
Besat Hospital
City
Hamedan
Postal code
6514845411
Phone
+98 81 1823 0461
Fax
Email
behnoud@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)