Comparison of fasciotomy of the testicular tunica albuginea outcomes in treating testicular torsion surgery in children referred to Imam Hossein (AS) hospital in Isfahan.
Comparison of fasciotomy of the testicular tunica albuginea outcomes in treating testicular torsion surgery in children
Design
This study is a non-blinded clinical trial with a parallel design and a control group. The research population will include all children with testicular torsion referred to Imam Hossein Hospital in Isfahan. A total of 64 eligible people will be selected conveniently. A simple random method is used for randomization and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted in Imam Hossein Hospital in Isfahan city, is non-blinded. The right testicle is rotated counterclockwise and the left testicle is rotated clockwise and will be placed in warm wet gauze.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children with abdominal pain and testicular pain and testicular swelling and placement in a transverse position in the scrotum; diagnosis of testicular torsion according to ultrasound; Informed consent; Age less than 14 years
Exclusion criteria: A testicle that has necrotic areas or is completely necrotic and there is no ability to hold the testicle; History of orchiopexy or inguinal hernia surgery
Intervention groups
The intervention group is the patients for whom fasciotomy, detorsion, and orchiopexy will be performed. Patients should undergo surgery within 6 hours. The control group is the patients for whom detorsion and orchiopexy will be performed without fasciotomy.
Main outcome variables
vascular spasms and flu; hematoma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N198
Registration date:2023-03-24, 1402/01/04
Registration timing:registered_while_recruiting
Last update:2023-03-24, 1402/01/04
Update count:0
Registration date
2023-03-24, 1402/01/04
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of fasciotomy of the testicular tunica albuginea outcomes in treating testicular torsion surgery in children referred to Imam Hossein (AS) hospital in Isfahan.
Public title
Comparison of fasciotomy of the testicular tunica albuginea outcomes in treating testicular torsion surgery in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with abdominal pain and testicular pain and testicular swelling and placement in a transverse position in the scrotum
Diagnosis of testicular torsion according to ultrasound
Informed consent
Age less than 14 years
Exclusion criteria:
A testicle that has necrotic areas or is completely necrotic and cannot hold the testicle
History of orchiopexy or inguinal hernia surgery
Age
From 14 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple random method, after identifying eligible patients, they will be randomly assigned a three-digit dedicated code. The last digit on the right determines the patient group. If this number is 0, 1, 2, 3, 4, it will be assigned in the first intervention group, and if this number is 5, 6, 7, 8, 9, it will be assigned in the second intervention group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of medical School, Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-05-23, 1401/03/02
Ethics committee reference number
IR.MUI.MED.REC.1401.083
Health conditions studied
1
Description of health condition studied
Testicular rotation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
vascular spasms and flu
Timepoint
Before surgery, one hour and 24 hours after surgery
Method of measurement
Sonography
2
Description
Hematoma
Timepoint
After surgery
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group is the patients for whom fasciotomy, detorsion, and orchiopexy will be performed. Patients should undergo surgery within 6 hours.First, the patient is put under general anesthesia, and after making a skin incision on the scrotum and opening the subcutaneous tissue and tunica vaginalis, the testicle is taken out first, detour is performed, and blood supply is established. For torsion of the left testicle, first the testicle is rotated clockwise, and for the right testicle, we do the opposite, i.e. it is rotated counterclockwise. For fasciotomy, a cut is first made on the tunica albuginea, and a flap of the tunica vaginalis is placed on the incision site and fixed with PDS=4_0 thread (ethicon company).
Category
Treatment - Surgery
2
Description
The control group is the patients for whom detorsion and orchiopexy will be performed without fasciotomy.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Mehrdad Hossinpour
Street address
Ostandari St., Imam Hossein Hospital
City
Isfahan
Province
Isfehan
Postal code
8174673581
Phone
+98 31 3386 6266
Email
Hossinpour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research and Technology,Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Dr. Mehrdad Hossinpour
Position
Member of the faculty of Isfahan University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric and neonatal surgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
Hossinpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Hossinpour
Position
Member of the faculty of Isfahan University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric and neonatal surgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
Hossinpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Hossinpour
Position
Member of the faculty of Isfahan University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric and neonatal surgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahahn
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
Hossinpour@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD