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Evaluation of complication of tonsillectomy by Cold dissection versus bipolar diathermy

Protocol summary

Summary
Study objective: evaluation of complication of tonsillectomy by Cold dissection versus bipolar diathermy(ligature). Design: randomized, not controlled by placebo, unicentered, phase 1 trial. Inclusion criteria: patients with recurrent or chronic tonsillitis; sleep apnea; presence of debris in tonsillar crypts; adenotonsillar hypertrophy with snoring. Exclusion criteria: severe asthma; coagulopathy; diabetes mellitus; sickle cell anemia; neurologic deficits; acute infection; simultaneous myringotomy or VT insertion; simultaneous lymph node biopsy; socially inaccessible(no telephone or car). Sample size:82. Intervention: bipolar diathermy(ligature) surgery. Intervention time: 22.6.2013-20.3.2015. Primary outcome: pain, bleeding.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102113976N2
Registration date: 2013-12-17, 1392/09/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-17, 1392/09/26
Registrant information
Name
Javaneh Jahanshahi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0020
Email address
j.jahanshahi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of complication of tonsillectomy by Cold dissection versus bipolar diathermy
Public title
Evaluation of complication of tonsillectomy by Cold dissection versus bipolar diathermy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with recurrent or chronic tonsillitis; sleep apnea; presence of debris in tonsillar crypts; adenotonsillar hypertrophy with snoring. Exclusion criteria: severe asthma; coagulopathy; diabetes mellitus; sickle cell anemia; neurologic deficits; acute infection; simultaneous myringotomy or VT insertion; simultaneous lymph node biopsy; socially inaccessible(no telephone or car).
Age
From 15 years old to 40 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan university of medical sciences
Street address
Hamedan
City
Hamedan
Postal code
6514845411
Approval date
2013-04-09, 1392/01/20
Ethics committee reference number
16/35/9/44/پ/د

Health conditions studied

1

Description of health condition studied
Chronic tonsillitis
ICD-10 code
J35
ICD-10 code description
Chronic diseases of tonsils and adenoids

Primary outcomes

1

Description
pain
Timepoint
24 hours postoperation,1 week, 2 weeks, 4 weeks postoperation
Method of measurement
visual analogue scale

2

Description
bleeding
Timepoint
24 hours postoperation , 1 week, 2 weeks, 4 weeks postoperation
Method of measurement
milliliter

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: bipolar diathermy(ligature): tonsills are removed by bipolar cautery scissors and hemostasis is established. Surgery time is documented from mouth gag insertion to its removal. Bleeding volume is documented, too by looking at the suction bottle.
Category
Treatment - Surgery

2

Description
control group: tonsillectomy is done by cold dissection method. Tonsil and its capsule is removed by tonsil decoler. The inferior pole is cut by snare and hemostasis is established by vicryl 20.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Javaneh Jahanshahi
Street address
Besat hospital, Shahid Motahari boulevard, Hamedan.
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
research and technology depatment, hamedan university of medical sciences, shahid fahmideh street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Javaneh Jahanshahi
Position
Assistant professor
Other areas of specialty/work
Street address
ENT department, Besat hospital
City
Hamedan
Postal code
6514845411
Phone
+98 81 1264 0020
Fax
+98 81 1267 1717
Email
jahanshahi287@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Javaneh Jahanshahi
Position
Assistant professor
Other areas of specialty/work
Street address
ENT department, Besat hospital
City
Hamedan
Postal code
6514845411
Phone
+98 81 1264 0020
Fax
+98 81 1267 1717
Email
jahanshahi287@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Javaneh Jahanshahi
Position
Assistant professor
Other areas of specialty/work
Street address
ENT department, Besat hospital
City
Hamedan
Postal code
6514845411
Phone
+98 81 1264 0020
Fax
+98 81 1267 1717
Email
jahanshahi287@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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