Objective: Adenotonsillar hypertrophy is a common disorder among children without proper treatment may lead to considerable problems. Although the consequences of this disorder have been studied by many researchers, we decided to evaluate the changes of pulmonary function test in these children after adenotonsillectomy and also the correlation between clinical and spirometric parameters. Design: We conduct a before- after clinical trial on children with Adenotonsillar hypertrophy in Alzahra Hospital, Isfahan. Forty children with a diagnosis of upper airways obstruction due to adenotonsillar hypertrophy enroll in this study. Setting and conduct: Children with co-morbidity and other cause of airways obstruction exclude. Spirometric parameters are gathered and patients will operate for Adenotonsillectomy. Forty days later, patients are called for another spirometry again. In addition, to assess disease severity, symptom score is defined. Finally the pre and post procedure parameters are analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508176699N2
Registration date:2015-10-18, 1394/07/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-18, 1394/07/26
Registrant information
Name
Mehrdad Rogha
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3664 0352
Email address
rogha@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to compare pulmonary function tests before and after adenotonsillectomy in adenotonsillar hypertrophy
Public title
Pulmonary Tests After Adenotonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All children presented enlarged tonsils i.e. hypertrophy more than 2 +/ (degrees III and IV), according to Brodsky classification will be enrolled.
Exclusion criteria: Patients with cardiopulmonary diseases, neurological involvement, obese children (BMI more than 30 kg/m2), those with other causes of nasal obstruction such as polyps, nasal septal deviations and thoracic skeletal deformity will be excluded.
Age
From 5 years old 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
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
388441
Health conditions studied
1
Description of health condition studied
Enlargement of tonsils
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils
2
Description of health condition studied
Enlargement of adenoids
ICD-10 code
J35.2
ICD-10 code description
Hypertrophy of adenoid
Primary outcomes
1
Description
spirometric factors
Timepoint
preoperation and 40 days after it
Method of measurement
spirometry
Secondary outcomes
empty
Intervention groups
1
Description
Adenotonsillectomy in rose position and by sharp dissection method is done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital, Isfahan
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Mehdi nematbakhsh
Street address
Isfahan University of Medical Sciences, Hezarjarib Av., Isfahan, Iran
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Zhale Amini,MD
Position
Otolaryngology Resident
Other areas of specialty/work
Street address
ENT department, Alzahra hospital, Soffeh Av.
City
Isfahan
Postal code
Phone
+98 913 308 7832
Fax
Email
JA61057@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Mehrdad Rogha,MD
Position
Assistant professor
Other areas of specialty/work
Street address
Otolaryngology ward, Kashani Hospital,Isfahan
City
Isfahan
Postal code
Phone
+98 913 111 4856
Fax
Email
rogha@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
MOSTAFA RAISI
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)