This study is a single blind, randomized clinical trial. The purpose of this study is comparison between recurrence and complications of two methods of surgery (hydrocelotomy and hydrocelectomy) in the treatment of hydrocele in pediatrics who are candidates for surgical in Imam Reza hospital of Kermanshah.
A total of 70 patients are randomly allocated into two groups surgery (hydrocelotomy or hydrocelectomy).
Both groups will be followed and compared at first week, third month and sixth month after surgery for recurrence and complications (Damage to spermatic vessels and cord element, bleeding, wound infection, and hematoma).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013013112321N1
Registration date:2013-09-22, 1392/06/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
Registrant information
Name
Zahra Ghasemnejad
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6303
Email address
ghasemnejad.zahra@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences, Vice-chancellor for Research and technology
Expected recruitment start date
2013-10-15, 1392/07/23
Expected recruitment end date
2014-03-15, 1392/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of two surgical methods in the treatment of pediatrics with hydrocele
Public title
Comparative of two surgical methods in the treatment of pediatrics with hydrocele
Purpose
Treatment
Inclusion/Exclusion criteria
The criteria for inclusion of study are: children below 12 years old who are candidates for treatment of hydrocele in Imam Reza hospital of Kermanshah; non-communicating simple hydrocele.
The criteria for exclusion of study are: communicating hydrocele and testicular pathology in the same time; opposite testicle cryptorchidism and Inguinal hernia.
Age
To 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Kermanshah University of Medical Sciences. Research center
Street address
University Reseach Center, No.2 flat, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
6154896587
Approval date
2012-12-15, 1391/09/25
Ethics committee reference number
42513
Health conditions studied
1
Description of health condition studied
hydrocele
ICD-10 code
N43.3
ICD-10 code description
hydrocele of spermatic cord, testis or tunica vaginalis
Primary outcomes
1
Description
Recurrence
Timepoint
At the first week, third and sixth months
Method of measurement
corresponding to physical examination
Secondary outcomes
1
Description
Hematoma
Timepoint
At the first week, third and sixth months
Method of measurement
corresponding to physical examination
2
Description
Damage to spermatic vessels and cord element
Timepoint
At the first week, third and sixth months
Method of measurement
corresponding to physical examination
3
Description
bleeding
Timepoint
At the first week, third and sixth months
Method of measurement
corresponding to physical examination
4
Description
wound infection
Timepoint
At the first week, third and sixth months
Method of measurement
corresponding to physical examination
Intervention groups
1
Description
hydrocelotomy
(The cutting on hydrocele sac that make open and drain the fluid and relieve the hydrocele)
Category
Treatment - Surgery
2
Description
hydrocelectomy
(Removal of part or all of a hydrocele sac that causes loss of space of fluid and hydrocele treatment)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital of Kermanshah
Full name of responsible person
Zahra Ghasemnejad
Street address
General surgery ward, Imam Reza hospital, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
University reseach center, No.2 flat, Shahid Beheshti Blvd, Kermanshah university of medical sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Ghasemnejad
Position
Resident of General Surgery
Other areas of specialty/work
Street address
University reseach center, No.2 flat, Shahid Beheshti Blvd, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6158878888
Phone
+98 83 1427 6303
Fax
+98 83 1427 6310
Email
Ghasemnejadz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Omid Amanollahi
Position
Pediatric Surgeon
Other areas of specialty/work
Street address
University reseach center, No.2 flat, Shahid Beheshti Blvd, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6158965478
Phone
+98 83 1839 4919
Fax
+98 83 1839 4920
Email
Oamanolahi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Ghasemnejad
Position
Resident of General Surgery
Other areas of specialty/work
Street address
University reseach center, No.2 flat, Shahid Beheshti Blvd, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6158878888
Phone
+98 83 1427 6303
Fax
+98 83 1427 6310
Email
Ghasemnejadz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)