The effect of testosterone injection on the results of hypospadias surgery
Design
The study is a randomized, community-based, and pragmatic clinical trial consisting of 60 patients in 2 parallel groups with double-blind design
Settings and conduct
This study is a randomized clinical trial, double-blind at a time period from 2022 to 2023. The subjects of the study included all patients with hypospadias referred to Tabriz Children's Hospital which was treated as primary and non-consecutive. After entering the study and obtaining consent, for all patients (control and intervention group) at the moment of entering the study, according to the hypospadias, diagnostic and therapeutic measures are performed according to the physician's decision-making
Participants/Inclusion and exclusion criteria
Inclusion criteria: All hypochondriacs patients aged between 6 months and 5 years. Exclusion criteria: Dissatisfaction of parents Patient who can't be followed up after surgery for complications History of circumcision History of any kind of surgery
Intervention groups
Intervention group: The children will receive 2 ng/kg testosterone enanthate two weeks before surgery.Control group: The control group will not receive any preoperative treatment.
Main outcome variables
Glans and penis size, Incidence of urethrocutaneous fistula, Strictures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047702N4
Registration date:2022-07-13, 1401/04/22
Registration timing:prospective
Last update:2022-07-13, 1401/04/22
Update count:0
Registration date
2022-07-13, 1401/04/22
Registrant information
Name
Reza Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 2321 0333
Email address
dr.ramezanireza70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of testosterone injection on the results of hypospadias surgery
Public title
Testosterone injection in hypospadias surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All hypochondriacs patients
Age between 6 months and 5 years
Exclusion criteria:
Dissatisfaction of parents
Patient who can't be followed up after surgery for complications
History of circumcision
History any kind of surgery
Age
From 6 months old to 5 years old
Gender
Male
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Medical School
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2022-06-15, 1401/03/25
Ethics committee reference number
IR.TBZMED.REC.1401.257
Health conditions studied
1
Description of health condition studied
Hypospadias
ICD-10 code
Q54.1
ICD-10 code description
Hypospadias, penile
Primary outcomes
1
Description
Glans and penis size
Timepoint
1week,3 months and 6 months after surgery
Method of measurement
cone shape glans- central meatus- slit like meatus
Secondary outcomes
1
Description
complications
Timepoint
1 week, 3 months and 6 months after repair
Method of measurement
Evaluation of urethrocutaneous fistula, stricture, disease recurrence
Intervention groups
1
Description
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.
Category
Treatment - Surgery
2
Description
Control group: The control group will not receive any treatment before the hypospadias repair operation.