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Comparison of complications after surgery in undescended testicle orchiopexy with an inguinal incision with inguinal and scrotal incision methods.

Protocol summary

Study aim
Comparison of complications in two methods of transinguinal orchiopexy and standard method in palpable testicles of children under two years old
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 100 patients. A table of random numbers was used for randomization.
Settings and conduct
Method: Patients with non-palpable testicle who referred to the Mardani Azari children's hospital clinic in tabriz town from March 1402 to March 1402 are included in the study. Inclusion and exclusion criteria are applied and informed consent is obtained from parents. Then the intervention is done in two control and case groups. In the control group, after the initial surgical procedures, a tunnel is created in the canal to the scrotum, and the testicle is placed inside the dartos muscle pouch with skin incision. In the case group, the scrotum bag is pulled up to the wound and the testicle is fixed in the sub-dartuspouch.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with unilateral palpable undescended testicles Exclusion criteria: Non- palpable testis intra-abdominal testis Absence of the testicles in the evaluation before surgery Severely atrophic testis Bilateral undescended testis The existence of other anomalies associated genetic disorder.
Intervention groups
Intervention group: Trans-inguinal orchiopexy Comparison group: conventional orchiopexy
Main outcome variables
Outcomes: During surgery: Scrotal appearance after surgery and skin traction, surgery time, and complication during surgery( ischemia, hemorrhage, hematoma, inability to create inadequate spermatic cord length) One week and one month after surgery: Scrotal appearance and complication( include infection, dehiscence, edema, hematoma and ecchymosis. Three months after surgery: appearance ultra-sonographic finding about volume and dimension of testicle.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150124020767N5
Registration date: 2024-03-02, 1402/12/12
Registration timing: registered_while_recruiting

Last update: 2024-03-02, 1402/12/12
Update count: 0
Registration date
2024-03-02, 1402/12/12
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
2024-02-29, 1402/12/10
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of complications after surgery in undescended testicle orchiopexy with an inguinal incision with inguinal and scrotal incision methods.
Public title
orchiopexy in undescended testicle.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unilateral undescended testicles who have palpable testicles in the inguinal canal.
Exclusion criteria:
Non-palpable testis Intra-abdominal testis Absence of testis in preoperative imaging Severely atrophic testis Bilateral undescended testes Associated anomalies with undescended testis Associated genetic anomalies
Age
From 6 months old to 24 months old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization :Simple, Tools used in randomization:based on the random.org online site. Patient will be randomly assigned to two intervention and comparison groups after diagnosis and evaluation of inclusion and exclusions criteria.allocation to two groups will be done through the random.org online site without changing the sequence.In this site we enter the "numbers " section ten the "sequence generator" . As the total sample for this study is 100 psubjects the smallest value will be 1 and the largest us 100. The column should be 2 to get two series of random numbers. Then then we click on "get sequence" . The resulting sequence will be two columns of numbers that each number shows the number of entering patient and each column shows each study group that is intervention or control. The resulting numbers in each group will be entered the Excel to make them from smallest to largest. Concealment will not be done due to impossiblity.
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
Ethics committee of Tabriz Medical University of Medical Sciences
Street address
Mardani Azari Children hospital, Tabriz, east Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2023-12-18, 1402/09/27
Ethics committee reference number
IR.TBZMED.REC.1402.679

Health conditions studied

1

Description of health condition studied
Undescended testicle, unilateral
ICD-10 code
Q53.1
ICD-10 code description
Undescended testicle, unilateral

Primary outcomes

1

Description
complication rate of undescended testis surgery
Timepoint
One week and one month and three months after surgery
Method of measurement
Observation and ultra-sonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Patients who refer to the children's hospital clinic from the February 2024 until the end of 19th May 2024 are examined first. If there is no testicle in the scrotum unilaterally and the same testicle is touched in the inguinal canal, they are included in the study. Patients with age below six months and age above two years are excluded from the study. For all patients, ultrasound is performed and the findings including the location of the testicles and the dimensions and volume of both testicles are recorded. Patients are admitted and consent to study is obtained from the parents. Patients are examined by attending physician and anesthesiologist. Initial tests include blood cell count is obtained. Patients with concomitant diseases and chronic disorders are excluded from the study. According to the order of entry into the study, patients are divided and odd numbers are included in the intervention group and even numbers are included in the comparison group. Parents are unaware of the groups. For both groups of interventions, the same general anesthesia is performed according to the anesthesia references. In the patients of the intervention group, the inguinal incision is first opened in the Langer lines of the inguinal canal area. Then the process vaginalis is removed and the necessary parts, including the vas deferens and spermatic blood and lymphatic vessels, are separated from it. The vaginal process is repaired and the patient's hernia is repaired. Then the gubernaculum is cut and hemostasis is done. The vas deferens and the spermatic vessels and the related testicle are preserved. Retro-peritoneum dissection is performed to free the cord so that the testicle reaches the scrotum and sufficient length of the spermatic vessels is created. The path of the testicle to the scrotum is opened by the surgeon's finger. Then, without cutting the scrotum, the skin of the scrotum is pulled up to the inguinal incision site by the surgeon's finger guide with a blunt tool. A pouch is formed between the skin of the scrotum and the dartos fascia. The testicle is placed inside poach and fixed to the skin of the scrotum with an absorbable suture. Then the skin along with the testicle is pulled down to the natural place. Then, the oblique external aponeurosis and subcutaneous tissue are repaired.
Category
Treatment - Surgery

2

Description
Control group: Patients who refer to the children's hospital clinic from the January 2024 until the end of 19th May 2024 are examined first. If there is no testicle in the scrotum unilaterally and the same testicle is touched in the inguinal canal, they are included in the study. Patients with age below six months and age above two years are excluded from the study. For all patients, ultrasound is performed and the findings including the location of the testicles and the dimensions and volume of both testicles are recorded. Patients are admitted and consent to study is obtained from the parents. Patients are examined by attending physician and anesthesiologist. Initial tests include blood cell count is obtained. Patients with concomitant diseases and chronic disorders are excluded from the study. According to the order of entry into the study, patients are divided and odd numbers are included in the case group and even numbers are included in the control group. Parents are unaware of the groups. For both groups of interventions, the same general anesthesia is performed according to the anesthesia references. In the patients of the intervention group, the inguinal incision is first opened in the Langer lines of the inguinal canal area. Then the process vaginalis is removed and the necessary parts, including the vas deferens and spermatic blood and lymphatic vessels, are separated from it. The vaginal process is repaired and the patient's hernia is repaired. Then the gubernaculum is cut and hemostasis is done. The vas deferens and the spermatic vessels and the related testicle are preserved. Retro-peritoneum dissection is performed to free the cord so that the testicle reaches the scrotum and sufficient length of the spermatic vessels is created.A tunnel is created on the path of the canal to the scrotum, and the skin of the scrotum is incised, and a pouch is created with a clamp between dartos fascia and scrotal skin. Then with a clamp inserted into the inguinal canal, the testicle is pulled down into the scrotal pouch. The testicle is placed inside the pouch of the dartos fascia. The tunica vaginalis around the testicle is fixed with vicryl absorbable thread in two places, and then dartos is repaired. Then, the oblique external aponeurosis and subcutaneous tissue are repaired.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahra Mardani Azari Children hospital
Full name of responsible person
Masoud Jamshidi
Street address
Zahra Mardani Azari Children hospital, Mardani Azari street, Khavaran town,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 911 151 9217
Email
masoudjamshidi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7311
Fax
+98 41 3334 4280
Email
masoudjamshidi@gmail.com
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
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Zahra Mardani Azari Children hospital, Mardani Azari street, Khavaran town,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 41 3159 5050
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
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Zahra Mardani Azari Children hospital, Mardani Azari street, Khavaran town,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 41 3159 5050
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
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Zahra Mardani Azari Children hospital, Mardani Azari street, Khavaran town,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 41 3159 5050
Email
masoudjamshidi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Individuals can request to receive data and documents at the m.khaaste@gmail.com and the data will be sent after the approval of the university.according to the university guidelines, the data can only be provided to university researchers. There is no limit to data analysis.data must be remain confidential. Any publication of the whole or part of the data requires the permission and approval of the original researcher so that bias does not occur in the data analysis. In case of publication, researcher must cite the owner of the data or article.
From where data/document is obtainable
Email address: m.khaaste@gmail.com or jamshidim@tbzmed.ac.ir Phone number:989127981446
What processes are involved for a request to access data/document
After registering the application in the email address, the correspondence with the university will be done to get approval and after receiving the approval, the data will be sent.this process will take about one week.
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