]>
IRCT20220218054055N1 IRCT 2022-10-29 Tabriz University of Medical Sciences distal hypospadias surgery procedures Comparison of the results of distal hypospadias surgery using ventral and dorsal dart flaps 2022-11-22 anticipated 60 Complete https://irct.ir/trial/66231 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, On 60 cards, the sequence of the surgical procedure was written in 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 patient's parents and the person who evaluated the final outcomes were 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 surgery will be operated by the Tubularized incised plate (TIP) technique, and ventral dartus flap will be used to cover the urethra. Intervention 2: Control group: hypospadias surgery will be operated by the Tubularized incised plate (TIP) technique, and dorsal dartus flap will be used to cover the urethra. Yes - There is a plan to make this available What will be shared: Part of the data on the outcome of hypospadias surgery methods 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 is Behzad Lotfi Email: lotfib@tbzmed.ac.ir How to obtain: Requesting data and study documents will be done by correspondence with the person responsible for updating the study information Comments:
public Javad Aliasgarzadeh khiavi
Urology Ward,Imam Reza Hospital, Golgasht St.,Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 j.aliasgarzadeh@yahoo.com Tabriz University of Medical Sciences scientific Behzad Lotfi
Urology ward, Emam Reza Hospital, Golgasht ave.
Tabriz Iran (Islamic Republic of) 5166614756 0413347054 blotfi@gmail.com 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 - Surgery Intervention group: hypospadias surgery will be operated by the Tubularized incised plate (TIP) technique, and ventral dartus flap will be used to cover the urethra. Control group: hypospadias surgery will be operated by the Tubularized incised plate (TIP) technique, and dorsal dartus flap will be used to cover the urethra. Glans and penis size. Timepoint: 1week, 3 months and 6 months after surgery. Method of measurement: HOSE (Hypospadias Objective Scoring Evaluation) check list. 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 2022-08-29 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)