Investigating the iatrogenic dorsal chordee on preputial graft results in patients with proximal hypospadias and sever chordee
Design
A single-arm, unblinded, non-randomized, phase 2 clinical trial of 40 patients.
Settings and conduct
Place of operation: Urology operating room, Bahonar Hospital, Kerman. Patients are in one group. No blinding.
Participants/Inclusion and exclusion criteria
inclusion conditions: Candidate patients for proximal hypospadias repair
Patients between the ages of 6 months and 18 years
Conditions of non-entry: circumcised children
Cases with less than 30 degree ventral curvature
Genital skin diseases such as lichen planus
Cases of micropenis that after 3 cycles of hormone therapy with testosterone, the length and width of the penis is less than 2 standard deviations of the normal length of the penis for the age.
Intervention groups
Intervention group: In this group, the skin around the penis is deglazed (the skin is removed from the foreskin to the tip of the penis). Then the curvature of the penis is examined. If the ventral cord is more than 30 degrees, we have to cut the urethral plate. Therefore, we use a two-step method. An incision is made in the midline, and the foreskin is sutured with a 6-0 Vicryl thread in the ventral part of the penis shaft, and hematoma is prevented. One or two sutures with 4-0 nylon thread are placed on the dorsal part of the penile fascia to create a dorsal cord of 20 to 30 degrees. It is for the reason that the grafts done on the ventral surface do not wrinkle and become fibrotic. Then in the second stage, which is to be done six months later. The ventral grip is tubularized and the tissue layers are repaired, and the Suchornylon Dural plication of the previous time is removed.
Main outcome variables
The results were obtained in the first stage in terms of fibrosis or contracture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240808062694N1
Registration date:2024-08-16, 1403/05/26
Registration timing:prospective
Last update:2024-08-16, 1403/05/26
Update count:0
Registration date
2024-08-16, 1403/05/26
Registrant information
Name
nosratolah ahmadpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4428 8300
Email address
nosrat.ahmaddna@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-10, 1403/06/20
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the iatrogenic dorsal chordee on preputial graft results in patients with proximal hypospadias and sever chordee
Public title
Examining the results of skin grafting in patients with congenital urethral defects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for proximal hypospadias repair
Patients between the ages of 6 months and 18 years
Exclusion criteria:
Circumcised children
Cases with less than 30 degree ventral curvature
Genital skin diseases such as lichen planus
Cases of micropenis that after 3 cycles of hormone therapy with testosterone, the length and width of the penis is less than 2 standard deviations of the normal length of the penis for the age.
Age
From 6 months old to 18 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital - Kerman University of Medical sciences
Street address
Clinical Research Development Unit, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2024-08-03, 1403/05/13
Ethics committee reference number
IR.KMU.AH.REC.1403.086
Health conditions studied
1
Description of health condition studied
Hypospadias, penoscrotal
ICD-10 code
Q54.2
ICD-10 code description
Hypospadias, penoscrotal
2
Description of health condition studied
Hypospadias, perineal
ICD-10 code
Q54.3
ICD-10 code description
Hypospadias, perineal
Primary outcomes
1
Description
The results were obtained in the first stage in terms of fibrosis or contracture
Timepoint
6 months after the first surgery
Method of measurement
Ruler and goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the skin around the penis is deglazed (the skin is removed from the foreskin to the tip of the penis). Then the curvature of the penis is examined. If the ventral cord is more than 30 degrees, we have to cut the urethral plate. Therefore, we use a two-step method. An incision is made in the midline and the foreskin is sutured in this area with a 6-0 Vicryl thread in the ventral part of the penis shaft and hematoma is prevented. One or two sutures with 4-0 nylon thread are placed on the dorsal part of the penile fascia to create a dorsal cord of 20 to 30 degrees. It is for the reason that the grafts done on the ventral surface do not wrinkle and become fibrotic. Then in the second stage, which is to be done six months later. The ventral grip is tubularized and the tissue layers are repaired, and the Suchornylon Dural plication of the previous time is removed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Amir Reza Sadeghi Far
Street address
Kerman, Qarani St. - Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarh@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpoor
Street address
Research and Technology Office, Samiya Crossroads (Tahmasababad), at the beginning of Ibn Sina Street, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
VCR@KMU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nosratolah Ahmadpoor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Taleb Amoli Blvd., Janbazan Blvd., Isar 5, Niazi 1, Toranj 1, end of alley No. 34
City
Amol
Province
Mazandaran
Postal code
4615895796
Phone
+98 11 4428 8300
Fax
Email
nosrat.ahmaddna@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahboubeh Mirzaei
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Jomohri Blvd., Hoshang Mardadi Blvd., Hatef Esfahani, north one east two second house on the right
City
Kerman
Province
Kerman
Postal code
7618813346
Phone
+98 34 3213 3489
Email
mirzaeimahboubeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nosratolah Ahmadpoor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Taleb Amoli Blvd., Janbazan Blvd., Isar 5, Niazi 1, Toranj 1, end of alley No. 34
City
Amol
Province
Mazandaran
Postal code
4615895796
Phone
+98 11 4428 8300
Fax
Email
nosrat.ahmaddna@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study, a part of the information including the results of the iatrogenic long-term curd formation in the results of the pleuropus test in proximal hypospadias patients will be shared with those interested in the treatment field after deidentifying the individuals.
When the data will become available and for how long
2 to 6 months after the statistical analysis of the data
To whom data/document is available
Doctors and researchers offer treatment
Under which criteria data/document could be used
In order to use the results and during the written request
What processes are involved for a request to access data/document
The purpose of accessing and using the data is to request an email to the author, a second email in case of no response as a reminder, to confirm the identity of the requester by the public respondent, to send the documentation file.