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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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26 March 2018 |
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Main ID: |
IRCT20180318039124N1 |
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Date of registration:
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2018-03-24 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The effect of baby aspirin on reduction of edema and ecchymosis
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Scientific title:
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Investigation the effect of baby aspirin on reduction of edema and ecchymosis in patients undergoing rhinoplasty |
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Date of first enrolment:
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2018-04-04 |
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Target sample size:
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100 |
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Recruitment status: |
Pending |
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URL:
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http://en.irct.ir/trial/30222 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: block randomization with quadrilateral blocks, Blinding description: Aspirin drugs and placebo boxes have a similar appearance so the patients are blinded ( When giving a written consent, it will be explained to the patients that for improving the accuracy of the results, the patients should be blinded but they are either in aspirin or placebo group. The cons and pros of each treatment option will be explained). Assignment of the patients into two groups will be done by the student (researcher) and the surgeon who will also evaluate the patients after surgery for the edema and ecchymosis won,t be aware of the assignment so he is blinded.
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Phase:
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2-3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dorna Karimi
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Address:
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Ali Ebne Abi Taleb Hospital, Khalije Fars Blv, Zahedan
9916789547
Zahedan
Iran (Islamic Republic of) |
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Telephone:
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+98 54 3329 5715 |
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Email:
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dor.karimi@zaums.ac.ir |
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Affiliation:
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Zahedan University of Medical Sciences |
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Name:
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Dorna Karimi
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Address:
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Khatam al Anbiya Hospital, Jame Jam Blv, Zahedan
9916789547
Zahedan
Iran (Islamic Republic of) |
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Telephone:
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+98 54 3329 5715 |
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Email:
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dor.karimi@zaums.ac.ir |
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Affiliation:
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Zahedan University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients candidate for rhinoplasty
Exclusion criteria: Allergy to non-steroidal anti-inflammatory drugs (NSAIDs)
Having coagulation disorders
Having active infection
Having a history of gastric ulcer or bleeding
Age minimum:
no limit
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rhinoplasty.
Encounter for procedures for purposes other than remedying health state
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Intervention(s)
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Intervention 1: Intervention group: Receiving 80 mg daily baby aspirin from the second day for 7 days. Intervention 2: Control group: Recieving daily baby aspirin pacebo from the second day for 7 days.
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Primary Outcome(s)
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Edema and ecchymosis. Timepoint: On post-operative days 3, 5, 7, 10 and 14. Method of measurement: 0-4 Point scoring tool.
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Source(s) of Monetary Support
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Zahedan University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Zahedan University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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