Comparison of the complications of transinguinal orchiopexy and standard orchiopexy of palpable testicles in children under two years old referred to Tabriz Children's Hospital
Evaluation of complications in both trans-inguinal orchiopexy and standard orchiopexy in children under two years old
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 100 patients. The random number table was used for randomization.
Settings and conduct
Two surgical procedures are performed in Tabriz Children's Hospital on the undescended testicles of children aged six to twenty-four months. Methods include trans-inguinal orchiopexy and conventional method as control.
Patients are unaware of the type of surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Palpable undescended testis
Exclusion criteria:
Unpalpable undescended testis
Intra-abdominal testis
No evidence of testis in pre-operative imaging
Severely atrophic testis
Bilateral undescended testis
The presence of other anomalies along with the undescended testis
Associated Genetic Disorders
Intervention groups
1: case group: Trans-inguinal orchiopexy
2: control group: conventional orchiopexy
Main outcome variables
Testicular volume, Scrotal appearance, Testicular ischemia, Duration of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150124020767N4
Registration date:2020-05-28, 1399/03/08
Registration timing:registered_while_recruiting
Last update:2020-05-28, 1399/03/08
Update count:0
Registration date
2020-05-28, 1399/03/08
Registrant information
Name
masoud jamshidi
Name of organization / entity
tabriz medical sciences university
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2257
Email address
jamshidim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the complications of transinguinal orchiopexy and standard orchiopexy of palpable testicles in children under two years old referred to Tabriz Children's Hospital
Public title
Comparison of the complications of of transinguinal orchiopexy and standard orchiopexy of palpable testicles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Palpable undescended testis
Exclusion criteria:
Unpalpable undescended testis
Intra-abdominal testis
No evidence of testis in pre-operative imaging
Severely atrophic testis
Bilateral undescended testis
The presence of other anomalies along with the undescended testis
Associated Genetic Disorders
Age
From 6 months old to 10 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, Individual, Using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blinded. Patients after obtaining inclusion criteria to enter the study and obtain consent, according to the table of random numbers, will be divided into two groups. They will not interfere in determining the type of treatment and will not know the type of treatment before the treatment process.
The analyzer will not be aware of the type of treatment (because it receives the data as a spss file in two separate groups, one and two).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz children"s Hospital, Sheshglan St.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Approval date
2020-05-03, 1399/02/14
Ethics committee reference number
IR.TBZMED.REC.1399.094
Health conditions studied
1
Description of health condition studied
Undescended testis
ICD-10 code
Q53.1
ICD-10 code description
Undescended testicle, unilateral
Primary outcomes
1
Description
Complications of orchiopexy
Timepoint
One week - one month and three months after surgery
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Testicular volume
Timepoint
Before surgery and three months after surgery
Method of measurement
Ultrasonography
2
Description
Scrotal appearance
Timepoint
One week - one month and three months after surgery
Method of measurement
Inspection. Three groups without skin retraction - minimal retraction - severe scrotal retraction
3
Description
Tissue ischemia
Timepoint
In duration of surgery
Method of measurement
Inspection-Ischemic testicular discoloration
4
Description
Duration of surgery
Timepoint
After surgery
Method of measurement
The watch ( time in minute)
Intervention groups
1
Description
Intervention group: Trans-inguinal orchiopexy. In this group, first by inguinal incision, the skin and the inguinal canal are opened in the Langer's lines. The vaginalis process is then separated and the necessary components, including the vas deferen, blood vessels, and spermatic cord, are preserved. The vaginalis process is repaired and the patient's hernia is corrected. Gubrenaculum is then discontinued. Retroperitoneal dissection is performed to release the cord so that the testicle reaches the scrotum and enough spermatic vessels length are formed. A tunnel is created along the canal to the scrotum, and the skin of the scrotum is returned to the inguinal incision with a blunt-skin clamp. The tonica vaginalis around the testicle is fixed in two places with absorbable vicryl sutures, and then the dartus layer is repaired, and then the external iliac apineurosis and skin is repaired . Patient is examined for skin tension and the time of surgery and complications during surgery (including ischemia, bleeding, hematoma and the impossibility of creating sufficient length in the spermatic cord). The patient will be discharged on the evening of the day of surgery if the clinical condition is appropriate. Follow-up examinations will be performed in the following week and one month after surgery . Three months after the surgery, the appearance will be checked and the ultrasound will be done in terms of the size and dimensions of the testicles and their location (problems caused by ischemia and atrophy).
Category
Treatment - Surgery
2
Description
Control group: In patients referred to this group, first the skin and the inguinal canal are opened in the longitudinal lines by inguinal incision. The vaginalis process is then removed and the necessary components, including thevas deferens, blood vessels, and spermatic lymphatic vessels, are preserved. The vaginalis process is repaired and the patient's hernia is corrected. The gubernaculum is then cut. Retroperitoneal dissection is performed to release the cord so that the testicle reaches the scrotum and enough spermatic vessels are formed. A tunnel is created along the canal to the scrotum, cut through the skin incision in the scrotal area, and a scalpel is inserted into the dartus muscle through the scrotal wound. With the clamp inserted into the inguinal cavity, the testicle is pulled into the scrotal wound. The testis is placed inside the dartus muscle sac. The tonic vaginalis around the testicle is fixed in two places with absorbable vicryl sutures, and then the dartus is repaired, and then the external iliac aponeurosis and skin is repaired .Patient is examined for skin tension and the time of surgery and complications during surgery (including ischemia, bleeding, hematoma and the impossibility of creating sufficient length in the spermatic cord). The patient will be discharged on the evening of the day of surgery if the clinical condition is appropriate. Follow-up examinations will be performed in the following week and one month after surgery . Three months after the surgery, the appearance will be checked and the ultrasound will be done in terms of the size and dimensions of the testicles and their location (problems caused by ischemia and atrophy).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Masoud Jamshidi
Street address
Sheshglan
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Email
masoudjamshidi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Daneshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3334 4280
Email
Research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Jamshidi
Position
Assissted professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Sheshglan
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Email
Masoudjamshidi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Jamshidi
Position
Assissted professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Sheshglan
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Email
Masoudjamshidi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Jamshidi
Position
Assissted professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Sheshglan
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Email
masoudjamshidi@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
Yes - There is 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
All potential data can be shared after unidentifiable people
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
N/A
From where data/document is obtainable
Email
What processes are involved for a request to access data/document