Evaluation of diameter of lumbar vein, renal vein, and gonadal vein in left kidney nephrectomy on the back table and its relationship with the prevalence of varicocele
En Evaluation of diameter of lumbar vein, renal vein, and gonadal vein in left kidney nephrectomy on the back table and its relationship with the prevalence of varicocele
Design
The study is a randomized, community-based, and pragmatic clinical trial consisting of 30 patients in 2 groups with a double-blind design
Settings and conduct
This study will be carried out at Tabriz Imam Hospital in a two-blind manner
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate for nephrectomy surgery, Not having congenital genitourinary problems.Exit criteria: History of inguinal herniorrhaphy, History of orchiopexy, Patients with a history of coagulation disorders.
Intervention groups
En Intervention group: Patients are evaluated for clinical varicocele before surgery, then underwent left-sided nephroctomy, during the operation, the diameter of the lumbar vein, renal vein and gonadal vein will be evaluated. Patients are re-evaluated for varicocele after 4 months
Main outcome variables
Varicocele prevalence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047702N3
Registration date:2022-05-20, 1401/02/30
Registration timing:registered_while_recruiting
Last update:2022-05-20, 1401/02/30
Update count:0
Registration date
2022-05-20, 1401/02/30
Registrant information
Name
Reza Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 2321 0333
Email address
dr.ramezanireza70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-22, 1401/02/02
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of diameter of lumbar vein, renal vein, and gonadal vein in left kidney nephrectomy on the back table and its relationship with the prevalence of varicocele
Public title
Correlation of venous diameter in nephrectomy with the prevalence of varicocele
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for nephrectomy surgery
Not having congenital genitourinary problems
Exclusion criteria:
History of inguinal herniorrhaphy
History of orchiopexy
Patients with a history of coagulation disorders.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who evaluated the final outcomes was unaware of the random allocation process and the type of treatment performed. Data were analyzed by a statistical expert who was separated from the study process and unaware of all the processes performed
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 School
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2022-03-02, 1400/12/11
Ethics committee reference number
IR.TBZMED.REC.1400.1201
Health conditions studied
1
Description of health condition studied
varicocele
ICD-10 code
I86.1
ICD-10 code description
Scrotal varices
Primary outcomes
1
Description
Measuring testis
Timepoint
size in ml before and 3 months after surgery
Method of measurement
Using a pair of calipers
2
Description
Prevalence of varicocele
Timepoint
3 months after surgery
Method of measurement
through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, patients who underwent left-sided nephrectomy are evaluated for varicocele prevalence for 3 months. Varicocele is clinically divided into three grades: Grade 1 varicoceles are palpable only during Valsalva's maneuver; grade 2 varicoceles are palpable without Valsalva's maneuver, and grade 3 varicoceles are visible and palpable without Valsalva's maneuver.
Category
Treatment - Surgery
2
Description
Control group: In control group patients will be evaluated for clinical varicocele, prior to renal transplantation surgery.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Ward,Imam Reza Hospital,
Full name of responsible person
Afshar Zomorodi
Street address
Urology ward, Emam Reza hospital, Golgasht ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 938 425 7137
Email
zomorrodiaf@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiee
Street address
Golgasht Street. Research and Technology, University of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 914 117 0855
Email
hajebrahimis@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?