Determining the effect of varicocelectomy with and without inguinal herniorrhaphy on the severity of scrotum pain in patients with varicocele.
Design
A clinical trial with a control group, with parallel groups, double-blind, phase 3 will be conducted on 146 patients. Rand function of Excel software will be used for randomization.
Settings and conduct
This study will be conducted on patients with painful varicocele in Shahid Beheshti Hospital in Hamadan. In this study, eligible patients will be randomly assigned to two groups. In one group of patients, varicocelectomy surgery will be performed with inguinal herniorrhaphy and in the other group, varicocelectomy surgery will be performed without inguinal herniorrhaphy. The study will be conducted in a double-blind manner. Patients and the person who evaluates the outcome of pain after surgery will be unaware of performing or not performing inguinal herniorrhaphy during varicocelectomy
Participants/Inclusion and exclusion criteria
The participants in the study are patients aged 18 to 65 years with varicocele accompanied by pain. Patients who have painless varicocele or have surgical contraindications for varicocelectomy or herniorrhaphy will not be included in the study.
Intervention groups
In one group of patients, varicocelectomy will be performed with inguinal herniorrhaphy . In the other group, varicocelectomy surgery will be performed without inguinal herniorrhaphy .
Main outcome variables
The main result of this study is the varicocele pain severity in the first week, first month and third month after surgery compared to before surgery, which is evaluated by the visual analogue scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N26
Registration date:2022-12-29, 1401/10/08
Registration timing:prospective
Last update:2022-12-29, 1401/10/08
Update count:0
Registration date
2022-12-29, 1401/10/08
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of varicocelectomy with or without inguinal herniorrhaphy on Scrotum pain in patients with varicocel
Public title
The effect of inguinal herniorrhaphy on scrotal pain after varicocelectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having varicocele
Having symptoms of Scrotum pain
Exclusion criteria:
Having varicocele without pain
Having contraindications for varicocelectomy or herniorrhaphy
Age
From 18 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
We made 146 cards and write letter I on 73 for intervention and on the other 73 letter C for the Control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter ( I or C) patients will be assigned to intervention (varicocelectomy with inguinal herniorrhaphy) or control (varicocelectomy without inguinal herniorrhaphy) group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the fact that the patient is under spinal anesthesia during the operation, he will not notice the type of intervention. Also, the person who evaluates the outcome of scrotal pain will be unaware of whether or not inguinal herniorrhaphy was performed during varicocelectomy, so the study will be double blinded .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
Ethics committee of Hamadan University of Medical Science, shahid fahmideh Ave, Hamadan. Iran
City
Hamadan
Province
Hamadan
Postal code
6517789971
Approval date
2022-05-07, 1401/02/17
Ethics committee reference number
IR.UMSHA.REC.1401.133
Health conditions studied
1
Description of health condition studied
varicocel
ICD-10 code
B01.9
ICD-10 code description
Varicella without complication
Primary outcomes
1
Description
Scrotum pain intensity changes
Timepoint
Before surgery, one week, one month and three months after surgery
Method of measurement
With Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Performing varicocelectomy surgery with inguinal herniorrhaphy
Category
Treatment - Surgery
2
Description
Intervention group: Performing varicocelectomy surgery without inguinal herniorrhaphy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Dr Sasan Mehrabi
Street address
Ghaem Sq, Eram Blv, Shahid Beheshti hospital, Hamedan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0283
Email
Mehrabi.sasan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokohi
Street address
Ethics committee of Hamedan University of medical scienceShahid Fahmide Ave, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh Ave. medicine school, Department of community medicine, Hamadan. Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Sasan Mehrabi
Position
Associated profesor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Ghaem Sq, Eram Blv, Shahid Beheshti Hospital, Hamadan. Iran
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
9838380704081
Email
Mehrabi.sasan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
مربی
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh St, Faculty of Medicine, Department of Community medicine, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Email
a.moradi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available