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IRCT20200608047702N4 IRCT 2022-07-13 Tabriz University of Medical Sciences Testosterone injection in hypospadias surgery The effect of testosterone injection on the results of hypospadias surgery 2022-08-23 anticipated 60 Complete https://irct.ir/trial/64492 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample size was 60 participants (30 people in each group). The block randomization method was developed by an epidemiologist collaborator using version 13 of Stata software. To conceal the random allocation process, 60 treatment cards were written in sequential order, then the cards were placed in sealed envelopes. On each envelope, a random code was written with no sequences that only the methodologist was aware of the code. When the physician announced a patient's eligibility, the methodologist provided the envelope, Blinding description: The person who evaluated the final outcomes was unaware of the random allocation process and the type of treatment performed. Data were analyzed by a statistical expert who was separated from the study process and unaware of all the processes performed. N/A Hypospadias. Intervention 1: Intervention group: Repair of hypospadias will be done 2 weeks after intramuscular injection of a single dose of testosterone 2 mg/kg by Aburihan company. Post-operative complications include: urethrocutaneous fistulas, stricture, and the average length and circumference of the penis will be measured after the operation. Intervention 2: Control group: The control group will not receive any treatment before the hypospadias repair operation. Yes - There is a plan to make this available What will be shared: Part of the data on the outcome of testosterone injection in hypospadias surgery is for sharing When: Access will be 6 months after the results are printed. To whom: Urological specialists in coordination with the presenter Conditions: The use of data to improve patients' treatment processes is safe Where to obtain: The person responsible for updating study information danial farhadi Email: danifarhadi20@gmail.com How to obtain: En Requesting data and study documents will be done by correspondence with the person responsible for updating the study information Comments:
public Behzad Lotfi
Urology ward, Emam Reza Hospital, Golgasht ave.
Tabriz Iran (Islamic Republic of) 5166614756 0413347054 blotfi@gmail.com Tabriz University of Medical Sciences scientific Fahimeh Kazemi Rashed
Urology ward, Emam Reza hospital, Golgasht ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 kazemirashedf@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) All hypochondriacs patients Age between 6 months and 5 years 6 months 5 years Male Dissatisfaction of parents Patient who can't be followed up after surgery for complications History of circumcision History any kind of surgery Q54.1 Hypospadias, penile Treatment - Surgery Treatment - Drugs Intervention group: Repair of hypospadias will be done 2 weeks after intramuscular injection of a single dose of testosterone 2 mg/kg by Aburihan company. Post-operative complications include: urethrocutaneous fistulas, stricture, and the average length and circumference of the penis will be measured after the operation. Control group: The control group will not receive any treatment before the hypospadias repair operation. Glans and penis size. Timepoint: 1week,3 months and 6 months after surgery. Method of measurement: cone shape glans- central meatus- slit like meatus. Complications. Timepoint: 1 week, 3 months and 6 months after repair. Method of measurement: Evaluation of urethrocutaneous fistula, stricture, disease recurrence. Tabriz University of Medical Sciences Approved 2022-06-15 Ethics Committee of Tabriz Medical School International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)