Aim of the study is comparison of cold and liquid diet versus routine Iranian dish on post-tonsillectomy morbidity. This was a double blind randomized clinical study in a single center (Dastgheib University Hospital Shiraz-Iran). Physician and statistician as assessors were blind. Patients were divided in two groups; control group (100 patients) which recommended on routine post tonsillectomy diet; that is cold and liquid. Intervention group (100 patients), with no diet limitation, can use regular Iranian dish. Inclusion criteria are: 1) age range 3-15 years old; 2) patients who undergo tonsillectomy. Tonsillectomy due to three or more severe recurrent attacks of tonsillitis within each two consecutive years; 3) educated parents at least at the level of high school. Exclusion criteria are: 1) pre operative medical problems such as asthma, diabetes, coagulation disorders, cardiovascular disease, basic metabolic disorder, immune system deficiency and chronic liver or renal disease; 2) Inadequate follow-up and incomplete questionnaires. Primary outcomes are pain and post operative bleeding within 10 days after operation. Pain will be evaluated by Visual Analog Scale by trained parents at home. Post operative bleeding will be confirmed by otolaryngologist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012115496N6
Registration date:2016-07-21, 1395/04/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-21, 1395/04/31
Registrant information
Name
Sareh Roosta
Name of organization / entity
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5323
Email address
namazi_balini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cold and liquid diet versus routine Iranian dish on post-tonsillectomy morbidity
Public title
Comparison of cold and liquid diet versus routine Iranian dish on post-tonsillectomy pain and bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) age range 3-15 years old; 2) patients who undergo tonsillectomy. Tonsillectomy due to three or more severe recurrent attacks of tonsillitis within each two consecutive years; 3) educated parents at least at the level of high school.
Exclusion criteria: 1) pre operative medical problems such as asthma, diabetes, coagulation disorders, cardiovascular disease, basic metabolic disorder, immune system deficiency and chronic liver or renal disease; 2) Inadequate follow-up and incomplete questionnaires.
Age
From 3 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2016-06-22, 1395/04/02
Ethics committee reference number
IR.sums.med.rec.1395.14
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J35.1, J35
ICD-10 code description
Hypertrophy of tonsils, Hypertrophy of tonsils with hypertrophy of adenoids
Primary outcomes
1
Description
Post-tonsillectomy pain
Timepoint
within 10 days after surgery
Method of measurement
Visual Analog Scale (VAS)-by trained parents at home
2
Description
Post-tonsillectomy bleeding
Timepoint
within 10 days after surgery
Method of measurement
Observation by ENT specialist
Secondary outcomes
empty
Intervention groups
1
Description
Control group receives routine cold and liquid post tonsillectomy diet.
Category
Prevention
2
Description
Intervention group, without diet limitation, can use regular Iranian dish.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital
Full name of responsible person
Dr. Mohammad Faramarzi
Street address
Hafez Street, Next to National Garden
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
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, Shiraz 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
Center for Development of Clinical Studies, Vice Chancellor of Research and Technology, Shiraz Unive
Full name of responsible person
Sareh Roosta
Position
MSc of Biostatistics
Other areas of specialty/work
Street address
Nemazee Square,Center for Development of Clinical Research of Nemazee Hospital
City
Shiraz
Postal code
Phone
+98 71 3612 5323
Fax
Email
Roosta.Sareh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Otolaryngology, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Faramarzi
Position
Associate Professor of Otolaryngology
Other areas of specialty/work
Street address
Department of Otolaryngology, Khalili Hospital, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3629 1478
Fax
Email
Faramarzi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Center for Development of Clinical Studies of Nemazee Hospital, Vice Chancellor of Research and Tech
Full name of responsible person
Sareh Roosta
Position
MSc of Biostatistics
Other areas of specialty/work
Street address
Center for Development of Clinical Research of Nemazee Hospital, Nemazee Square
City
Shiraz
Postal code
Phone
+98 71 3612 5323
Fax
Email
Roosta.Sareh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)