This study was done with aim to Comparative Study of results of the hernia sac ligation surgery in Orchiopexy children with undescended testis. This study is a single blind clinical trial. The population will consist of children 1 to 10 years old with undescended testis and without clinical inguinal hernia and undergoing Orchiopexy Referring to Mohammad Kermanshahi hospital during the 2012-2013 . That 16 persons are selected as sample and randomly divided into two(8 members) exprimental and control groups. the hernia sac ligation surgery was performed in the experimental group while the control group do not cause the hernia sac ligation surgery. Then the hematoma and bleeding, hydrocele, wound infection, recurrence, swelling and cord inflammation was recorded and patients for 6 months and for: A week after the operation and one, three and six months after the operation were followed and both groups were compared.
Inclusion criteria: children 1 to 10 years old with undescended testis;written consent of the patient or the patient's guardian. Exclusion criteria: clinical inguinal hernia (visible) along with undescended testis;hernia stuck with undescended testis; deterrent hernia along with undescended testis; increased intra-abdominal pressure for any reason (dialysis, etc.) along with undescended testis.
General information
Acronym
A Comparative Study of Surgery results with and without Ligation hernia SAC in Orchiopexy Childrens
IRCT registration information
IRCT registration number:IRCT2015101214333N42
Registration date:2015-10-27, 1394/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-27, 1394/08/05
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2013-09-06, 1392/06/15
Expected recruitment end date
2014-09-06, 1393/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of Surgery results with and without Ligation hernia SAC in Orchiopexy Childrens with Undescended Testis
Public title
A Comparative Study of results of Ligation hernia Surgery SAC in Orchiopexy Childrens with Undescended Testis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children 1 to 10 years old with undescended testis;written consent of the patient or the patient's guardian. Exclusion criteria: clinical inguinal hernia (visible) along with undescended testis;hernia stuck with undescended testis; deterrent hernia along with undescended testis; increased intra-abdominal pressure for any reason (dialysis, etc.) along with undescended testis.
Age
From 1 year old to 10 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
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
Committee Ethics, Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-10-11, 1394/07/19
Ethics committee reference number
kums.rec.1394.97
Health conditions studied
1
Description of health condition studied
Undescended testicle, bilateral
ICD-10 code
Q53.2
ICD-10 code description
Undescended testicle, bilateral
Primary outcomes
1
Description
hematoma and bleeding
Timepoint
A week after the operation and one, three and six months after the operation
Method of measurement
According to the surgeon examination
2
Description
wound infection
Timepoint
A week after the operation and one, three and six months after the operation
Method of measurement
Based on the clinical symptoms and physician observation
3
Description
Swelling and cord inflammation
Timepoint
A week after the operation and one, three and six months after the operation
Method of measurement
According to the sonography and physician observation
4
Description
Recurrence after operation
Timepoint
A week after the operation and one, three and six months after the operation
Method of measurement
According to the sonography and physician observation
Secondary outcomes
empty
Intervention groups
1
Description
The hernia sac ligation surgery was performed in the experimental group, Then the hematoma and bleeding, hydrocele, wound infection, recurrence, swelling and cord inflammation was recorded and patients for 6 months and for: A week after the operation and one, three and six months after the operation were followed.
Category
Treatment - Surgery
2
Description
The hernia sac ligation surgery was not performed in the control group, Then the hematoma and bleeding, hydrocele, wound infection, recurrence, swelling and cord inflammation was recorded and patients for 6 months and for: A week after the operation and one, three and six months after the operation were followed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Dr. Zahra Kashanian
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, 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
Vice chancellor for research, 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Omid Amanollahi
Position
Pediatrician Surgery
Other areas of specialty/work
Street address
Mohammad Kermanshahi Hospital, Crossroads of Shirkhorshid
City
Kermanshah
Postal code
Phone
+98 833
Fax
Email
oamanollahi@Yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)