The effect of trendelenburg position on homeostasis of the site, during and after thyroidectomy
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessm
Settings and conduct
This clinical trial will research in zahedan university of medical sciense.
Participants/Inclusion and exclusion criteria
60 euthyroid pationt in the age between 18 and 70 years that candidate for thyroidectomy in the ali ebn abitaleb hospital of zahedan
Intervention groups
30 pationts in the control group and 30 pationts in the intervention group
Main outcome variables
Hemoestasis in thyroidectomy surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190502043447N1
Registration date:2020-11-16, 1399/08/26
Registration timing:prospective
Last update:2020-11-16, 1399/08/26
Update count:0
Registration date
2020-11-16, 1399/08/26
Registrant information
Name
Mohammad Attarzadeh Firouzabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3823 3254
Email address
attarzadeh.m65@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of trendelenburg position on surgery site hemostasis, during and after thyroidectomy
Public title
The effect of trendelenburg position on surgery site hemostasis, during and after thyroidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Between 18 and 70 Years Old
Candidate for Thyroidectomy
Exclusion criteria:
Diabetes mellitus
Over 70 and Under 18 Years Old
Bleeding disorder
Anticoagulan usage 48 hr before surgery
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method is used individually with the STATA software.
Blinding (investigator's opinion)
Double blinded
Blinding description
pationts and analyser dont know about that which group are they
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
Daneshgah ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817714379
Approval date
2019-07-10, 1398/04/19
Ethics committee reference number
IR.ZAUMS.REC.1398.141
Health conditions studied
1
Description of health condition studied
Thyroidectomy
ICD-10 code
Thyroidect
ICD-10 code description
Thyroidectomy
Primary outcomes
1
Description
Hemostasis afterThyroidectomy
Timepoint
During and after Thyroidectomy surgery
Method of measurement
Bleeding sites during surgery and hematoma or seroma after Thyroidectomy surgery
Secondary outcomes
1
Description
Patient satisfaction after surgery
Timepoint
The Day After Surgery
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
intervention group: Trendelenburg position in surgery
Category
Treatment - Surgery
2
Description
Control group: Without Trendelenburg position in surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebne Abitaleb Hospital
Full name of responsible person
Mohammad Attarzadeh
Street address
Salamat Blvd, Persian Gulf Expressway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Web page address
http://alihos.zaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Vice-president for Research and Technology
Street address
ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Attarzadeh Firouzabadi
Position
Resident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Salamat Blvd, Persian Gulf Expressway, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 35 3823 3254
Email
Attarzadeh.m65@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Attarzadeh Firouzabadi
Position
Resident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Salamat Blvd, Persian Gulf Expressway, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 35 3823 3254
Email
Attarzadeh.m65@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Attarzadeh Firouzabadi
Position
Resident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Salamat Blvd, Persian Gulf Expressway, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 35 3823 3254
Email
Attarzadeh.m65@gmail.com
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 include the outcomes of the two groups can be published after being unidentified.
When the data will become available and for how long
Access to information will be granted after article publishment.
To whom data/document is available
Data will be access by researchers from medical universities.
Under which criteria data/document could be used
Data will be access by researchers from medical universities.
From where data/document is obtainable
Dr mohammad attarzadeh. MD. General surgery resident
Email: attarzadeh.m65@gmail.com
Tell: +989124034539
Address:Ali ebne Abitaleb Hospital, Salamat Blvd, Persian Gulf Expressway, Zahedan
What processes are involved for a request to access data/document
The people that wanted the data should email requested the data.