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Comparison of the effects of two methods of Cold Dissection and "Tonsillectomy Bipolar Resection" in patients aged 5 to 15 years undergoing tonsillectomy with or without adenoidectomy

Protocol summary

Study aim
Determination and comparison of the effects of two methods of Cold desiccation and"Tonsillectomy Bipolar Resection"in tonsillectomy
Design
This study was a clinical trial with two parallel and three-blind groups that were selected based on Sequential.The surgical procedure of the first specimen is selected by coin, then the procedure of the later specimens is selected according to the schedule
Settings and conduct
groups includes 38 patients that undergo tonsillectomy with or without adenoidectomy in the ENT of Khalili Hospital,Shiraz.the patient & his parents,researcher,are blinded.Patients follow up for a week & patients with postoperative bleeding who require surgical intervention under general anesthesia are identified and a questionnaire including the following information will be provided:age,gender,surgical indication,bleeding time,The location of bleeding,the cause of hemorrhage
Participants/Inclusion and exclusion criteria
Inclusion criteria:Having consent to study,obtaining consent and full cooperation from parents of children,need for tonsillectomy,residing in Shiraz,children aged 5 to 15 years.Exclusion criteria:Lack of any preoperative infections,bleeding diseases,disorders in coagulation tests(PLT,P,PTT,INR), mental retardation,chronic underlying diseases (diabetes,cancer,etc.)
Intervention groups
In the first group,upper mucous membrane was given with a knife and then the blunt dissection was taken to separate the tension from the base,then the snare amputate the tonsile in the lower pole.In the second group,done by the Tonsillectomy Bipolar Resection method, the surgeon removes the special wire behind the tonsil,after fixing the wire, the coagulation button is pushed to simultaneously cut & coagulate
Main outcome variables
User friendly method;Bleeding during and after surgery;Postoperative pain;duration of surgery;duration of return to activity & normal diet;surgical cost

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190106042251N1
Registration date: 2019-08-17, 1398/05/26
Registration timing: retrospective

Last update: 2019-08-17, 1398/05/26
Update count: 0
Registration date
2019-08-17, 1398/05/26
Registrant information
Name
jamshid eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4257
Email address
jam_eslami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2019-04-04, 1398/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of two methods of Cold Dissection and "Tonsillectomy Bipolar Resection" in patients aged 5 to 15 years undergoing tonsillectomy with or without adenoidectomy
Public title
Efficiency of Tonsillectomy Bipolar Resection device in tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having satisfaction with the study Getting the consent and full cooperation of the parents of children The need for performing Tonsillectomy Staying in Shiraz Children in the age range of 5 to 15 years
Exclusion criteria:
Preoperative infection Having bleeding diseases Disturbances in coagulation tests (PLT, PT, PTT, INR) Having a mental retardation Chronic underlying diseases (diabetes, cancer, etc.)
Age
From 5 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 76
More than 1 sample in each individual
Number of samples in each individual: 38
.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients and their parents, researchers, clinical caregivers, and data analyzers are blind. Surgery is done by the ENT surgeon and the information is given to the researcher irrespective of the type of surgical procedure.Coding is also used to analyze data.
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
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2019-06-23, 1398/04/02
Ethics committee reference number
IR.SUMS.REC.1398.584

Health conditions studied

1

Description of health condition studied
Tonsillectomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
User-friendly device
Timepoint
Immediately after the intervention
Method of measurement
Davis & Venkatesh technology acceptance questionnaire

2

Description
The amount of bleeding during and after surgery
Timepoint
During the intervention, 1, 3 and 7 days after the intervention
Method of measurement
Subtracting the weight of blood-stained gauzes from the weight of surgical gauzes

Secondary outcomes

1

Description
Mortality
Timepoint
1, 3 and 7 days after the intervention
Method of measurement
Percentage of deaths in a month

Intervention groups

1

Description
Control group: In this group, tansillectomy is common with cold dissection. Adenoidectomy was performed in patients using Curettes and then a pack of nasopharyngeal for homeostasis was performed. In tonsillectomy, a first sharper dissection was made and a mucosal incision was performed with a knife. At the end, the snare will be used to amputate the tonsile in the lower pole. Patch and suture are also used to control bleeding.
Category
Treatment - Surgery

2

Description
Intervention group: Patients treated with Tonsillectomy Bipolar Ressection. As the surgeon draws the special wire behind the tonsils, then after the fixation of the wire, the coagulation button is pressed to simultaneously cut and coagulate.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Khalili hospital
Full name of responsible person
Fatemeh Fakhrealizadeh
Street address
Namazi Square, Khalili hospital
City
Shiraz
Province
Fars
Postal code
7185886479
Phone
+98 71 3632 2612
Email
Fakhrealizadeh@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3235 7282
Email
Ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Eslami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Surgical Technology
Street address
Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatemeh
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3647 4257
Email
Jam_Eslami@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Fakhrealizadeh
Position
tutor
Latest degree
Master
Other areas of specialty/work
Surgical Technology
Street address
Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatemeh
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3632 2612
Email
Fakhrealizadeh@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Fakhrealizadeh
Position
tutor
Latest degree
Master
Other areas of specialty/work
Surgical Technology
Street address
Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatemeh
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3632 2612
Email
Fakhrealizadeh@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data, except the device's technical map, can be shared after being unidentified.
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
All scholars working in academic and scientific institutions
Under which criteria data/document could be used
Creating a Better Quality and Performance Device for Tonsillectomy Under the Inventor of this Device (Researcher)
From where data/document is obtainable
For more information, please call 00989017680793 or email Fakhrealizadeh@sums.ac.ir
What processes are involved for a request to access data/document
Setting up a contract for any change in the invention of the researcher
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