Assessment of outcomes in distal hypospadias repair by Snodgrass method with and without Urethral plate incision
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 2021 to 2022. The subjects of the study included all patients with hypospadias and superficial chordee 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 hypospadias patients. Exclusion criteria: Dissatisfaction of parents Patient who can't be followed up after surgery for complications History of circumcision History any kind of penile surgery
Intervention groups
Intervention group: Hypospadias repair with Urethral plate incision, Control group: Hypospadias repair without Urethral plate incision
Main outcome variables
Incidence of urethrocutaneous fistula, Strictures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047702N2
Registration date:2022-02-02, 1400/11/13
Registration timing:prospective
Last update:2022-02-02, 1400/11/13
Update count:0
Registration date
2022-02-02, 1400/11/13
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
2022-02-09, 1400/11/20
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of outcomes in distal hypospadias repair by Snodgrass method with and without Urethral plate incision
Public title
Hypospadias repair by Snodgrass method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All hypospadias patients
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 6 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
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
Not 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
2021-07-12, 1400/04/21
Ethics committee reference number
IR.TBZMED.REC.1400.361
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
incidence of urethrocutaneous fistula
Timepoint
daily from the third day after surgery
Method of measurement
Physical examination
2
Description
Strictures
Timepoint
At the time of catheter removal, one month, three month, six month after surgery
Method of measurement
Physical examination
Secondary outcomes
1
Description
Edima and bleeding in surgical site
Timepoint
After surgery,daily for 7 days
Method of measurement
Observation and follow up
Intervention groups
1
Description
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
Category
Treatment - Surgery
2
Description
Control group: Hypospadias repair without Urethral plate, In this method,Tubularization of the urethral plate is performed without a dorsal mid-line relaxing incision.