150 patients candidate for tonsillectomy without underlying disease are matched based on age , gender. They will be allocated into groups of case and control. Study is single blinded and patients will not be aware of the intervention group. For the control group no hemorrhage controlling powder will be used, and for the intervention group chitohem powder will be used to control the bleeding. Scale of pain and bleeding, time of starting oral feeding, required amount of analgesic medication and time of formation of fibrin layer after surgery is compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608174374N2
Registration date:2017-04-24, 1396/02/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-24, 1396/02/04
Registrant information
Name
Seiedreza Seiedmohammaddoulabi
Name of organization / entity
shahid beheshti university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 3333 9755
Email address
s8371916@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hearing research centre of Loghman Hakim hospital , Shahid Beheshti University Of Medical Sciences
Expected recruitment start date
2016-10-20, 1395/07/29
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of haemostatic absorbable powder in tonsillectomy compare with using sutur in tonsillectomy
Public title
Study the effect of haemostatic absorbable powder in tonsillectomy surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate for tonsillectomy with age in range of 6-53 years old.
exclusion criteria: blood disorders; bleeding tendency
Age
From 6 years old to 53 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
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 Shahid Beheshti University Of Medical Scienses
Street address
Daneshgah Square, Shahid Chamran Highway
City
Tehran
Postal code
11799-43613
Approval date
2016-05-08, 1395/02/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.148
Health conditions studied
1
Description of health condition studied
Hypertrophy of tonsils
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils
Primary outcomes
1
Description
presence or abscence of bleeding
Timepoint
6,12,24 hours after surgery
Method of measurement
observation
2
Description
presence of fibrin membrane
Timepoint
6
Method of measurement
observation
3
Description
pain visual analogue scale
Timepoint
6"12"24 hours after surgery
Method of measurement
pain visual analogue scale
Secondary outcomes
1
Description
bleeding after surgery
Timepoint
24 hours after surgery
Method of measurement
observation
Intervention groups
1
Description
In case group we will use chitohem powder for control hemorrhagea after tonsillectomy.
Category
Treatment - Surgery
2
Description
In control group use suture in site of surgery for control hemorrhagea.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Navid Ahmadi roozbahani
Street address
Kamali street, Karegar street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Scienses
Full name of responsible person
Seyed Reza Seyed Mohammad Doulabi
Street address
Loghman Hakim Hospital, Kamali street, Karegar street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Scienses
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
Shahid Beheshti University Of Medical Sciens
Full name of responsible person
SeiedReza SeiedMohammadDoulabi
Position
Resident of otolaryngology
Other areas of specialty/work
Street address
Loghman Hakim Hospital , Kamali street ,Karegar street
City
Tehran
Postal code
11799-43613
Phone
+98 21 5102 5000
Fax
+98 51025000
Email
javad_9423@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Loghman Hakim Hospital
Full name of responsible person
Navid Ahmadi Roozbahani
Position
Specialized Ear,Nasal,Trachea
Other areas of specialty/work
Street address
Loghman Hakim Hospital, Kamali street, Karegar street
City
Tehran
Postal code
11799-43613
Phone
+98 21 5102 5000
Fax
+98 51025000
Email
navidar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Loghman Hakim Hospital
Full name of responsible person
Fahime Shamsian
Position
Medical Student
Other areas of specialty/work
Street address
Loghman Hakim Hospital, Kamali street, Karegar street
City
Tehran
Postal code
11799-43613
Phone
+98 21 3351 4399
Fax
+98 51025000
Email
fahime.shamsian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)