The comparision of complecation of of tonsillectomy in two methods of cold dissection and Bipolar with harmonic scalpel in patients with tonsillar hypertrophy and recurrent tonsillitis
Tonsillectomy is a common surgery. Indications for tonsillectomy in adults are chronic or recurrent tonsil infections, airway obstruction due to hypertrophy of the tonsils and suspicion of malignancy. In our study, single blind clinical trial, 32 patients 48-14 years old who are candidate for tonsillectomy are selected in Amir Alam Hospital. All patients will undergo tonsillectomy by one surgeon with similar method. In each patient tonsillectomy will be done randomly for each side by the harmonic method or cool dissection. The pain on each side on the first and the seventh days will be recorded. Primary outcome: time of surgery; The volume of intraoperative bleeding Secondary outcomes: postoperative bleeding; postoperative pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609179039N4
Registration date:2017-02-09, 1395/11/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-09, 1395/11/21
Registrant information
Name
Shahin Bastaninezhad
Name of organization / entity
Dep. ENT, AmirAlam Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6676 0269
Email address
shahinbastani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellorfor Research, School of Medicine,Tehran University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparision of complecation of of tonsillectomy in two methods of cold dissection and Bipolar with harmonic scalpel in patients with tonsillar hypertrophy and recurrent tonsillitis
Public title
The comparision of two methods of tonsillectomy convensional and harmonic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Tonsillar hypertrophy; recurrent tonsillitis
Exclusion criteria: Histiry of coagulopathy or anticoagulant therapy; past tonsillectomy; speech disorder; mental and developmental disorders
Age
From 14 years old to 48 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
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 Tehran University of Medical Sciences
Street address
Ghods Street, Keshavarz Boulevard
City
Tehran
Postal code
1417653761
Approval date
2016-02-10, 1394/11/21
Ethics committee reference number
IR.TUMS.REC.1394.1938
Health conditions studied
1
Description of health condition studied
Chronic tonsillitis
ICD-10 code
J35.1
ICD-10 code description
J35.1 Hypertrophy of tonsils Enlargement of tonsils
Primary outcomes
1
Description
surgery time
Timepoint
from incision to end of hemostasis of the same side
Method of measurement
Cronometer
2
Description
The volume of intraoperative bleeding
Timepoint
from incision to end of hemostasis of the same side
Method of measurement
Measuring the suction bottle and weightening of bloody gazes
Secondary outcomes
1
Description
postoperative bleeding
Timepoint
after operation
Method of measurement
Bleeding or no bleeding after surgery
2
Description
postoperative pain
Timepoint
first and seventh days after surgery
Method of measurement
Pain scale scoring system
Intervention groups
1
Description
Harmonic group: Side of tonsillectomy with harmonic scalpel in 32 patients
Category
Treatment - Surgery
2
Description
Cold dissection group: side of tonsillectomy in fasion of cold dissection with bipolar in 32 patients
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralam hospital
Full name of responsible person
Dr Alireza Safaee
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellorfor Research, School of Medicine,Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhondzadeh
Street address
Poursina street, Ghods Street, Enghelab street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellorfor Research, School of Medicine,Tehran University of Medical Sciences