Objectives: Comparison of standard inguinal varicocelectomy and varicocelectomy with gubernacular veins closure in severe varicocele treatment based on age, infertility time, and unilateral or bilateral surgery
Planning: Controlled randomized one-side blinded trial
Method: 78 patients with severe varicocele (based on physical exam and sonography) who admitted in Shohada-e Tajrish Medical Center allocated in one the case or control groups.
Inclusion criterion: men with severe varicocele.
Exclusion criteria: infertility due to other causes; chronic comorbidities such as diabetes melitus and other endocrinologic disorders; atrophic testes; past history of surgical procedures relating to genitalia.
Interventions:
Intervention group: Closure of varicose veins via inguinal approach and then delivering of testis outside of the scrotum via the same inguinal wound and closure of gubernacular veins and then replacement of testis into the scrotum
Control group: Satndard varicocelectomy. it means closure of varicose veins via inguinal approach
Primary outcome measures:
Semen count, Normal morphology rate in sperms, and Sperm motility rate 6 months after procedure
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092524166N2
Registration date:2016-11-29, 1395/09/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-29, 1395/09/09
Registrant information
Name
Hamidreza Qashqai
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 230 7789
Email address
qashqaee@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
LASER Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-05-01, 1395/02/12
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomised clinical assessment of varicocelectomy outcomes with gubernacular veins closure
Public title
Comparative assessment of varicocelectomy outcomes with and without gubernacular veins closure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: men with sever varicocele.
Exclusion criteria: infertility due to other causes; chronic comorbidities such as diabetes melitus and other endocrinologic disorders; atrophic testes; past history of surgical procedures relating to genitalia.
Age
From 15 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti university of medical sciences
Street address
Velenjak
City
Tehran
Postal code
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.185
Health conditions studied
1
Description of health condition studied
Scrotal varices (Varicocele)
ICD-10 code
186.1
ICD-10 code description
Varicocele
Primary outcomes
1
Description
Semen count
Timepoint
six months after surgical procedure
Method of measurement
Semen analysis
2
Description
Normal morphology rate in sperms
Timepoint
six months after surgical procedure
Method of measurement
Semen analysis
3
Description
Sperm motility rate
Timepoint
six months after surgical procedure
Method of measurement
Semen analysis
Secondary outcomes
1
Description
Procedure Failure
Timepoint
Six months after procedure
Method of measurement
Sperm analysis
2
Description
Operation side effects such as hemorrhage, infection and relapse of varicocele
Timepoint
1 month after procedure, 3 months after procedure and 6 months after procedure
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Closure of varicose veins via inguinal approach and then delivering of testis outside of the scrotum via the same inguinal wound and closure of gubernacular veins and then replacement of testis into the scrotum
Category
Treatment - Surgery
2
Description
Control group: Satndard varicocelectomy. It means closure of varicose veins via inguinal approach
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-e Tajrish Medical Center
Full name of responsible person
Dr. Farzad Allameh
Street address
Qods sq., Tajrish
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
LASER Application in Medical Sciences Research Center of Shahid Beheshti University of Medical Scien
Full name of responsible person
Dr. Mohammadreza Razzaghi
Street address
Shohada-e Tajrish Medical Center, Qods sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
LASER Application in Medical Sciences Research Center of Shahid Beheshti University of Medical Scien
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Qashqai
Position
Urology Resident
Other areas of specialty/work
Street address
Shohada-e Tajrish Medical Center
City
Tehran
Postal code
Phone
+98 912 230 7789
Fax
Email
qashqaee@sbmu.ac.ir; qashqaee@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Farzad Allameh
Position
Urologist
Other areas of specialty/work
Street address
Shohada-e Tajrish Medical Center, Qods sq.
City
Tehran
Postal code
Phone
+98 912 388 5545
Fax
Email
farzadallame@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Urology Department
Full name of responsible person
Dr. Hamidreza Qashqai
Position
Urology resident
Other areas of specialty/work
Street address
Shohada-e Tajrish Medical Center, Qods sq., Tajrish
City
Tehran
Postal code
Phone
00
Fax
Email
qashqaee@sbmu.ac.ir; qashqaee@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)