In this clinical trial 64 patients older than 18 years old suffering from varicocele referred to urology clinic candidate for surgical varicocelectomy randomly allocated in two groups.in both groups after taking informed consent form and approval of ethics committee, diagnosis of varicocele will be confirmed by physical examination or ultrasonography and semen analysis will be done for all of them. in presence of infertility, pain or abnormal sperm analysis varicocelectomy will be performed by surgical method without using loops or microscope.in first group (subinguinal) under general anesthesia in supine position with a 3 centimeter transverse incision on external inguinal ring skin and subcutaneous fat dissected and after separating vas deference and lymphatis, spermatic veins dissect and ligate by 3-0 silk suture. In second group skin will be incised as first group, but with incision on external oblique fascia cord mobilized and operation will done as first group.in both groups patients discharge after operation and will be followed one week next and exam for presence of hematoma, wound infection and pain by visual analogue scale . One and 3 months later they visit again and check by history, physical examination or ultrasonography for presence of hydrocele and recurrence of varicocele. After three month spermogram will be checked in all of them for success of operation and improvement of infertility .all data will be recorded and analyzed by SPSS software version 21 and analytical descriptive and Qi square tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710131323N12
Registration date:2017-10-20, 1396/07/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-20, 1396/07/28
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor of Yasuj University of Medical Sciences
Expected recruitment start date
2016-10-21, 1395/07/30
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of success rate and complications of inguinal and subinguinal varicocelectomy operation
Public title
comparison of inguinal and subinguinal varicocelectomy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:males suffering from varicocele with pain and impairment of spermogram aged more than 18
Exclusion criteria:noncooperation for followup,presence of morbid obesity with BMI >35,coincidence of inguinal hernia with varicocele,history of previous varicocelectomy and recurrence
Age
From 18 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Mottahari srteet, Yasuj, Iran
City
Yasuj
Postal code
Approval date
2016-12-30, 1395/10/10
Ethics committee reference number
IR.YUMS.REC.2016.150
Health conditions studied
1
Description of health condition studied
varicocele
ICD-10 code
186-1
ICD-10 code description
scrotal varices
Primary outcomes
1
Description
improvment of fertility and spermogram
Timepoint
befor and 3 months after operation
Method of measurement
with semen analysis
Secondary outcomes
1
Description
Pain relief
Timepoint
one week and one month after operation
Method of measurement
visit and examinatin and check by visual analogue scale
Intervention groups
1
Description
performing subinguinal varicocelectomy in supine position without using optic loop
Category
Treatment - Drugs
2
Description
performing inguinal varicocelectomy in supine position without using optic loop