Comparison of prevalence of post adenotonsillectomy hemorrhage requiring surgical intervention in hot dissection with cold dissection technique in children 3-10 years old admitted to Khatam-Ol-Anbia hospital of Zahedan during years 2016-18
The purpose of this study was to compare the frequency of bleeding requiring surgical intervention after adenotonsillectomy in two methods of hot dissection and cold dissection in 3-10 years old children. This study is a randomized, single-blind clinical trial that will be conducted in the ear, throat and nose ward of Khatam-Ol-Anbia Hospital of Zahedan. The study population included all 3-10 years old children who referred to the ENT clinic during the years of 2016-18 and are candidates for adenotonsillectomy. The inclusion criteria for entering the study include the absence of history of craniofacial surgery and other craniofacial diseases and craniofacial anomalies and the absence of coagulation disorders and immunodeficiency syndromes. Exclusion criteria include the use of anti-coagulant drugs and the lack of parental cooperation. The sample size is 60 person in each group. Patients are randomly divided into two groups, all patients undergo general anesthesia with the same protocol and adenotonsillectomy will be performed by one person in both groups. Adenotonsillectomy is performed in one of the groups by hot dissection and in other group by cold dissection method. After surgery, all patients will receive a same type of analgesic. Patients are then checked for variables such as the incidence of bleeding during the first 24 hours of the postoperative period or after 24 hours and the pain score 12 hours after the operation and one week after the operation and are registered in pre-prepared checklists.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050633838N1
Registration date:2017-11-01, 1396/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Esmaeil Rahmanian
Name of organization / entity
Zahedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3342 0417
Email address
esmaeil.rahmanian@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Zahedan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prevalence of post adenotonsillectomy hemorrhage requiring surgical intervention in hot dissection with cold dissection technique in children 3-10 years old admitted to Khatam-Ol-Anbia hospital of Zahedan during years 2016-18
Public title
Comparison of prevalence of post adenotonsillectomy hemorrhage requiring surgical intervention in hot dissection with cold dissection technique
Purpose
Treatment
Inclusion/Exclusion criteria
Major inclusion factors include absence of history of maxillofacial surgery؛ absence of history of other diseases of the ear, throat and nose and craniofacial anomalies؛ lack of history of underlying and systemic diseases؛ absence of hematologic diseases such as sickle cell anemia؛ absence of coagulation disorders؛ absence of immunodeficiency or immunodeficiency syndromes.
Major exclusion factors include use of anti-coagulant drugs؛ the lack of parental cooperation.
Age
From 3 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethics Committee of Zahedan university of medical sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR.ZAUMS.REC.1395. 102
Health conditions studied
1
Description of health condition studied
Acute tonsillitis, unspecified
ICD-10 code
J03.9
ICD-10 code description
Tonsillitis (acute): NOS follicular gangrenous infective ulcerative
Primary outcomes
1
Description
Hemorrhage
Timepoint
During one week after operation
Method of measurement
Physical examination
Secondary outcomes
1
Description
Pain
Timepoint
12 hours and one week after operation
Method of measurement
Numeric and visual scale of pain
Intervention groups
1
Description
Adenotonsillectomy by cold dissection technique which tonsils are dissected by sharp tools without use of electrocauter.
Category
Treatment - Surgery
2
Description
Adenotonsillectomy by hot dissection technique which tonsils are dissected by electrocautery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-Ol-Anbia Hospital
Full name of responsible person
Khatam-Ol-Anbia Hospital, Jam e Jam Avenue, Zahedan
Street address
Dr Reza Ghariby
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Zahedan University of Medical Sciences
Full name of responsible person
Dr Hushang Rafighdust
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
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 of Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Ghariby
Position
Assistant Professor
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5716
Fax
Email
esmaeil.rahmanian90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Ghariby
Position
Otolarangologist
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5717
Fax
Email
esmaeil.rahmanian90@outlook.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan university of medical sciences
Full name of responsible person
Dr Reza Ghariby
Position
Assistant professor
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5718
Fax
Email
esmaeil.rahmanian90@outlook.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)