Comparison of the results of distal hypospadias surgery using ventral and dorsal dart flaps
Design
The study is a randomized 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
In the intervention group, the ventral dartos flap is used to cover the urethra in the hypospadias surgery. In the control group, the dorsal dartos flap is used to cover the urethra in the hypospadias surgery.
Main outcome variables
Incidence of urethrocutaneous fistula, Strictures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220218054055N1
Registration date:2022-10-29, 1401/08/07
Registration timing:prospective
Last update:2022-10-29, 1401/08/07
Update count:0
Registration date
2022-10-29, 1401/08/07
Registrant information
Name
Behzad Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7328
Email address
lotfib@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of distal hypospadias surgery using ventral and dorsal dart flaps
Public title
distal hypospadias surgery procedures
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
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, 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 (investigator's opinion)
Double blinded
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
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
2022-08-29, 1401/06/07
Ethics committee reference number
IR.TBZMED.REC.1401.500
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
HOSE (Hypospadias Objective Scoring Evaluation) check list
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: hypospadias surgery will be operated by the Tubularized incised plate (TIP) technique, and ventral dartus flap will be used to cover the urethra.
Category
Treatment - Surgery
2
Description
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.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mardani Azar Children's Hospital
Full name of responsible person
Behzad Lotfi
Street address
Khavaran shahrak
City
Tabriz
Province
East Azarbaijan
Postal code
513377505
Phone
+98 41 3336 1018
Email
blotfi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiee
Street address
Golgasht Street. Research and Technology, University of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 914 117 0855
Email
hajebrahimis@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?