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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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25 February 2019 |
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Main ID: |
IRCT20180310039030N1 |
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Date of registration:
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2019-02-19 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of Surgical and non-surgical therapies in Infants with ureteropelvic junction obstruction
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Scientific title:
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Results of early pyeloplasty and maintenance therapy in asymptomatic infants with grade III and IV ureteropelvic junction obstruction(UPJO) |
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Date of first enrolment:
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2018-04-21 |
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Target sample size:
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30 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/30185 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization
Patients are randomly assigned to one of the two intervention and follow-up groups based on the last digit of the case file. Persons with even numbers categorise as the intervention group and the persons with odd numbers categorise in the follow-up group.
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Phase:
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N/A
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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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Khashayar Atqiaee
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Address:
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Mofid children Hospital ,Shariati Ave
15468- 155514
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 2222 7021 |
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Email:
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khashayar_atqiaee@sbmu.ac.ir |
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Affiliation:
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Shahid Beheshti University of Medical Sciences |
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Name:
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Khashayar Atqiaee
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Address:
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Mofid children Hospital,Shariati Ave
15468- 155514
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 2222 7021 |
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Email:
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khashayar_atqiaee@sbmu.ac.ir |
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Affiliation:
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Shahid Beheshti University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: All asymptomatic children under one year of age with ureteropelvic junction obstruction (UPJO) (grade 3 or 4 hydronephroses)
The kidney differential function (DRF) is based on the results of isotope scans at least 40% or higher.
Exclusion criteria: All children under one year of age with ureteropelvic junction obstruction( UPJO ) with symptoms such as urinary tract infections, palpable kidney pain
The presence of ureteral and kidney anomalies
Ultrasonography represents structural anomalies
voiding cystourethrogram (VCUG) represents urinary reflux and posterior urethral valve (PUV)
Age minimum:
1 month
Age maximum:
1 year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ureteropelvic Junction Obstruction.
Hydronephrosis with ureteropelvic junction obstruction
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Intervention(s)
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Intervention 1: Intervention group: asymptomatic patient under age of one year with ureteropelvic junction obstruction undergoing dismembered reduction pyeloplasty. Intervention 2: Control group: asymptomatic patient under age of one year with ureteropelvic junction obstruction undergoing maintenance therapy.Follow up visits to the treatment center at specific intervals. At monthly urine test, ultrasound and isotope scans at intervals of 3 months 6 months to 1 year to check the progression of the disease.
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Primary Outcome(s)
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The degree of Ureteropelvic Junction Obstruction. Timepoint: before intervention 1 week later 3 and 6 months later to one year. Method of measurement: Ultra sonography ,radioisotope scan.
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Source(s) of Monetary Support
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Shahid Beheshti University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Shahid Beheshti 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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