Objectives: To assess the effect of varicocelectomy with and without inguinal herniorrhaphy on scrotal pain in patients with varicocel.
Design: a single blind randomized clinical trial.
Setting and conduct: The eligible patients with painful varicocel who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) age of 18 to 65 years; (b) candidate for varicocelectomy.
Exclusion criteria: (a) varicocel without pain; (b) any contraindication for varicocelectomy or herniorrhaphy.
Intervention: varicocelectomy with inguinal herniorrhaphy.
Control: varicocelectomy without inguinal herniorrhaphy.
Primary outcome: measuring the pain severity one week, one month, and three months after surgery using VAS scale.
Secondary outcome: Nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504089014N60
Registration date:2015-04-25, 1394/02/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-25, 1394/02/05
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
2015-04-04, 1394/01/15
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of varicocelectomy with and without inguinal herniorrhaphy on scrotal pain in patients with varicocel: a single blind randomized clinical trial
Public title
Effect of varicocelectomy with and without inguinal herniorrhaphy on scrotal pain in patients with varicocel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 18 to 65 years; (b) candidate for varicocelectomy.
Exclusion criteria: (a) varicocel without pain; (b) any contraindication for varicocelectomy or herniorrhaphy.
Age
From 1 year old to 65 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: random assignment of the patients to the intervention and control groups using balance block randomization of 4 groups.
Blinding: patients will be under the local anesthesia and will not aware of the type of intervention. Therefore, the trial will be run as single blind.
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
2014-05-17, 1393/02/27
Ethics committee reference number
D/P/16/35/9/710
Health conditions studied
1
Description of health condition studied
Varicocel
ICD-10 code
I86.1
ICD-10 code description
Varicocele
Primary outcomes
1
Description
measuring the pain severity
Timepoint
one week, one month, and three months after surgery
Method of measurement
using VAS scale
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Varicocelectomy with inguinal herniorrhaphy
Category
Treatment - Surgery
2
Description
Varicocelectomy without inguinal herniorrhaphy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Ehsan Ghaneei
Street address
Shahid Beheshti Hospital, Eram 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
Shahid Beheshti Hospital
Full name of responsible person
Dr Ehsan Ghaneei
Position
Medical student
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
e_ghaneei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Sasan Mehrabi
Position
Pediatric Urologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
mehrabi.sasan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)