Objectives: To assess the effect of laparoscopy versus open surgery on the size and function of testis in patients with varicocele.
Design: a double blinded randomized clinical trial.
Setting and conduct: All eligible patients who are candidate for varicocelectomy and will refer to the Alvand Surgery Clinic or Motahary Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: (a); Patients with obvious unilateral or bilateral varicocele; (b) candidate for varicocelectomy.
Exclusion criteria: (a) history of inguinal herniorrhaphy of the same side; (b) history of orchiopexy of the same side.
Intervention: varicocelectomy using laparoscopy through under nipple.
Control: varicocelectomy using open surgery with high ligation method.
Primary outcome: (a) measuring testis size in ml before and 6 months after surgery using a pair of calipers; (b) semen analysis (number of sperm per mm3, sperm motility in percent, sperm morphology in percent) before and 6 months after surgery through laboratory methods.
Secondary outcome: (a) hydrocele, edema, and hematoma of testis one week after surgery through physical examination; (b) recurrence of varicocele 6 months after surgery through physical examination.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409299014N43
Registration date:2014-10-07, 1393/07/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-07, 1393/07/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-11-22, 1391/09/02
Expected recruitment end date
2013-10-24, 1392/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of laparoscopy versus open surgery on the size and function of testis in patients with varicocele: a double blinded randomized clinical trial
Public title
Effect of laparoscopy versus open surgery on the size and function of testis in patients with varicocele
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a); Patients with obvious unilateral or bilateral varicocele; (b) candidate for varicocelectomy.
Exclusion criteria: (a) history of inguinal herniorrhaphy of the same side; (b) history of orchiopexy of the same side.
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control group using paper sheets labeled surgery or laparoscopy.
Blinding: non-blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2012-11-22, 1391/09/02
Ethics committee reference number
D/P/16/35/9/3042
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 6 months after surgery
Method of measurement
using a pair of calipers
2
Description
semen analysis (number of sperm per mm3, sperm motility in percent, sperm morphology in percent)
Timepoint
before and 6 months after surgery
Method of measurement
through laboratory methods.
Secondary outcomes
1
Description
hydrocele, edema, and hematoma of testis
Timepoint
one week after surgery
Method of measurement
through physical examination
2
Description
recurrence of varicocele
Timepoint
6 months after surgery
Method of measurement
through physical examination
Intervention groups
1
Description
varicocelectomy using laparoscopy through under nipple.
Category
Treatment - Surgery
2
Description
varicocelectomy using open surgery with high ligation method
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alvand Surgery Center
Full name of responsible person
Dr Marzieh Zaree
Street address
Alvand Surgery Center, Mahdiah Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
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
Alvand Surgery Center
Full name of responsible person
Dr Marzieh Zaree
Position
Resident of Urology
Other areas of specialty/work
Street address
Alvand Surgery Center, Mahdiah Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0717
Fax
Email
marzieh.zaree@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alvand Surgery Center
Full name of responsible person
Dr Manoochehr Ghorbanpoor
Position
Urologist
Other areas of specialty/work
Street address
Alvand Surgery Center, Mahdiah Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0717
Fax
Email
mgh.ghorbanpoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)