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IRCT20200608047702N2 IRCT 2022-02-02 Tabriz University of Medical Sciences Hypospadias repair by Snodgrass method Assessment of outcomes in distal hypospadias repair by Snodgrass method with and without Urethral plate incision 2022-02-09 anticipated 60 Complete https://irct.ir/trial/61486 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not 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: Hypospadias repair with Urethral plate. In this method, making a longitudinal incision on the urethral plate (UP) with tubularization to make a neourethra incision and using protective dartus flap to cover the neourethra. Intervention 2: Control group: Hypospadias repair without Urethral plate, In this method,Tubularization of the urethral plate is performed without a dorsal mid-line relaxing incision. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: Access will be 6 months after the results are printed. To whom: Urologic 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 dr Reza Mehdipur Email:shaghayegh.ghasemi1400@gmail.com How to obtain: Requesting data and study documents will be done by correspondence with the person responsible for updating the study information Comments:
public Behzad lotfi
No.11, Urology Ward,Imam Reza Hospital, Golgasht St.,Tabriz, Iran
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 hypospadias patients 6 months 6 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 - Surgery Intervention group: Hypospadias repair with Urethral plate. In this method, making a longitudinal incision on the urethral plate (UP) with tubularization to make a neourethra incision and using protective dartus flap to cover the neourethra Control group: Hypospadias repair without Urethral plate, In this method,Tubularization of the urethral plate is performed without a dorsal mid-line relaxing incision. Incidence of urethrocutaneous fistula. Timepoint: daily from the third day after surgery. Method of measurement: Physical examination. Strictures. Timepoint: At the time of catheter removal, one month, three month, six month after surgery. Method of measurement: Physical examination. Edima and bleeding in surgical site. Timepoint: After surgery,daily for 7 days. Method of measurement: Observation and follow up. Tabriz University of Medical Sciences Approved 2021-07-12 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)