Choosing the right surgical method to improve the appearance and function of the penis and increase the health of the genital area in children with an indented penis
Design
Clinical trial with control group, with parallel groups, randomized, phase 2 on 60 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Patients are examined at the specialized clinic of pediatric surgery and after confirming the diagnosis and selecting patients with indications for surgery, the study is fully explained to the parents and they are included in the study if they wish. Patients are randomly assigned to the intervention and control groups. Then they are admitted to the operating room of Isfahan teaching hospitals and undergo the described surgery. At six months old, they are examined and interviewed in a specialized pediatric clinic. According to the type of intervention and surgical treatment, blinding is not possible.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children with conceales penis over 7 years old
Exclusion criteria:
Reluctance to continue participating in the plan.
Concomitant coagulation disorder
Intervention groups
In this study, to correct the hidden penis in children with the above diagnosis, from the autologous full-thickness skin interposition graft from the thigh area and embedding it in the trunk of the penis after releasing Dartus adhesions, the performance and outcomes investigated in the study were monitored in the post-operative examinations. and are checked. The control group consists of children with hidden penis who did not undergo the above surgery at the mentioned age for any reason.
Main outcome variables
Improving the appearance and function of the penis and increasing the hygiene of the genital area in children with hidden penis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230513058160N1
Registration date:2023-05-27, 1402/03/06
Registration timing:retrospective
Last update:2023-05-27, 1402/03/06
Update count:0
Registration date
2023-05-27, 1402/03/06
Registrant information
Name
Davud Moznebi Esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3236 7106
Email address
dr.moznebi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
2021-10-23, 1400/08/01
Actual recruitment end date
2022-11-21, 1401/08/30
Trial completion date
2023-05-20, 1402/02/30
Scientific title
Investigation of the outcome of full thickness thigh graft for the correction of concealed penis in boys aged 7 to 14 years
Public title
The result of full-thickness femoral graft for the correction of concealed penis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with concealed penis over 7 years old
Exclusion criteria:
Reluctance to continue participating in the plan
Concomitant coagulation disorder
Age
From 7 years old to 14 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
60
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
Ethics committee of Esfahan University of Medical Sciences
Street address
No.8 Pour gol afshan Ave Lonban Blv
City
Esfahan
Province
Isfehan
Postal code
8184664131
Approval date
2023-05-09, 1402/02/19
Ethics committee reference number
IR.MUI.MED.REC.1402.073
Health conditions studied
1
Description of health condition studied
Concealed penis
ICD-10 code
N48
ICD-10 code description
Other disorders of penis
Primary outcomes
1
Description
Phallus morphology
Timepoint
Pre-operative visit and visit one week and 1,3, 6 months after the operation
Method of measurement
The morphology of the penis is recorded by measuring the length of the penis from its root with finger pressure on both sides of the penis before surgery and in subsequent visits.
Secondary outcomes
1
Description
Phallus function
Timepoint
Before the operation and the interval of a week and 1, 3, 6 months after the operation
Method of measurement
Relevant training is given to the parents to check and record the function of the penis during discharge, which is an assessment of the improvement of the child's urinary erection during urination.
2
Description
Genital hygiene
Timepoint
Before the operation and the interval of a week and 1, 3, 6 months after the operation
Method of measurement
Evaluation of the reduction of subalternal debris after surgery is done by parents at home and by clinical examination by pediatric surgery specialist in post-operative visits.
Intervention groups
1
Description
Intervention group: After admitting the patient to perform the operation, he is placed under general anesthesia and placed in the low lithotomy position. After prep and drape, the genital area and lower limbs are placed in the field. A median longitudinal incision is made on the ventral penile skin from the phimotic ring to the penoscrotum junction. For traction with Prolene 5.0, a permanent suture is placed at a distance of 5 mm from the edge of the glans and remains until the end of the operation. A peripheral cut is created according to the initial opening. Degloving is performed by dissection of all the dartos fascia of the penis and fibrous tissues from the fascia of the pelvis. Then, after tying a tourniquet at the base of the penis and injecting normal saline, the amount of cord is checked. If the severity of the cord is more than 10 degrees, the cord is corrected by Dorsal Plication with 0-5 Prolen thread using the Nezbit method. The subcutaneous tissue of the junction of the penoscrotum is dissected ventrally at the 6 o'clock position. This simplifies the dissection of the fat tissue of the genital area from the back to the pubic ligaments at 12 o'clock. Then, a full thickness graft with a length of 1.5 times the defect and a width of 1 cm is removed from the non-dominant thigh and defatted. It is useful to use the inguinal skin because it is hairless and next to the penis, and the resulting scar is easily hidden under clothing. Then the graft is transferred to the operation site and fixed at 12, 3, and 9 o'clock, and at 6 o'clock the genital area of the graft is repaired in the form of a ring. 0-4 is sewn. Urethral catheter is inserted based on the age of the patient. Antibiotics are started during induction of anesthesia and are maintained for 3 to 5 days. It ends. After 48 hours, the dressing is removed and the color of the graft is checked
Category
Treatment - Surgery
2
Description
Control group: After admitting the patient for the operation, he is placed under general anesthesia and placed in the supine position. After preparation and drape of the genital area, a longitudinal incision is made on the skin of the abdominal penis from the phimotic ring to the junction of the penoscrotum. is created For traction with Prolene 5.0, a permanent suture is placed at a distance of 5 mm from the edge of the glans and remains until the end of the operation. A peripheral cut is created according to the initial opening. Degloving is performed by dissection of all the dartos fascia of the penis and fibrous tissues of the pelvic fascia. The subcutaneous tissue of the junction of the penoscrotum is dissected ventrally at the 6 o'clock position. This simplifies the dissection of the genital fat tissue from the back to the pubic ligaments at 12 o'clock. The urethral catheter is inserted based on the patient's age. Antibiotics are started during the induction of anesthesia and are maintained for 3 to 5 days. After 48 hours, the dressing is removed. In this surgical method, no graft is used and only adhesions and fibrous tissue are released.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Mehrdad Hosseinpour
Street address
Ebn Sina Ave, Sonbolestan Street
City
Esfahan
Province
Isfehan
Postal code
81486-53141
Phone
+98 31 3445 5051
Email
dr.moznebi@yahoo.com
Web page address
https://amin.mui.ac.ir
2
Recruitment center
Name of recruitment center
Imam Hossein Children's Hospital
Full name of responsible person
Mehrdad Hosseinpour
Street address
Isfahan, Imam Khomeini St., before Esteghlal Square, Imam Hossein Children's Educational Therapy Center
City
Esfahan
Province
Isfehan
Postal code
81951-63381
Phone
+98 31 3386 6266
Email
dr.moznebi@yahoo.com
Web page address
https://ehuch.mui.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mozhgan Mortazavi
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Davud Moznebi Esfahani
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 8 Pour Gol afshan Ave, Lonban Blvd, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8184664131
Phone
+98 31 3236 7106
Fax
Email
dr.moznebi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Davud Moznebi Esfahani
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 8 Pour Gol afshan Ave, Lonban Blvd, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8184664131
Phone
+98 31 3236 7106
Fax
Email
dr.moznebi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Davud Moznebi Esfahani
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 8 Pour Gol afshan Ave, Lonban Blvd, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8184664131
Phone
+98 31 3236 7106
Fax
Email
dr.moznebi@yahoo.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After de-identifying individual information, individual complications or unintended consequences are shared
When the data will become available and for how long
Access starts 1 year after results are published
To whom data/document is available
Access for researchers in the field of pediatric surgery, urology and plastic surgery
Under which criteria data/document could be used
The data can be used for reference in future researches
From where data/document is obtainable
The request will be made by email with the specialist assistant of Dr. Davud Moznabi and after providing the documents of the research project and the data used in the research by the applicant and after verifying the identity of the applicant.
dr.moznebi@yahoo.com
What processes are involved for a request to access data/document
Sending an email request and scientific and personal specifications, resume and documentary information can be requested for the research project
The data will be made available as soon as possible after the confirmation of the individual inquiry and research plan