This study is a prospective and randomized double-blind clinical trial. The aim of this study is compared result of two different surgical pediatric herniotomy technique with and without external fascia opening in children with inguinal hernia. Total of sample size is 400 children under 12 years old. Inclusion criteria are children undergoing inguinal hernia. The Children with Incarcerated hernia, hydrocele, sliding hernia will be excluded. The patients are randomly divided into two groups by blocked randomization. Patient and assessor of study do not know about grouping patients. This study is 2 trial phase. First group, herniotomy surgery is the Surface into Outer ring and without opening the fascia of external oblique muscle. Second group, herniotomy surgery is opening external oblique fascia and opening channel and closing the bag on the surface of the inner ring. Patient's health status In terms of damage to the nerves and blood vessels and hematoma and seroma and hydrocele and testicular edema, ischemic orchitis and testicular atrophy and climbing testicular will be recorded one week, one month, six months and one year after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041727446N1
Registration date:2016-04-29, 1395/02/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-29, 1395/02/10
Registrant information
Name
Shaghayegh Sherafatmand
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
sherafatmand.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compared result of two different surgical pediatric herniotomy techniques with and without external fascia opening in children with inguinal hernia
Public title
Comparison the results of two surgical methods for the treatment of hernias in children with inguinal hernia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: children with inguinal hernia; children under 12 years old. Exclusion Criteria: incarcerated hernia; hydrocele; sliding hernia; undescended testis; the underlying disease.
Age
To 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.AJUMS.REC.1394.478
Health conditions studied
1
Description of health condition studied
Inguinal Hernia
ICD-10 code
K40
ICD-10 code description
Inguinal Hernia
Primary outcomes
1
Description
Disease recurrence
Timepoint
one week, one month, six months and one year after surgery
Method of measurement
Visiting patients and physical examination
2
Description
Satisfaction with the operation
Timepoint
one week, one month, six months and one year after surgery
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
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 Of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shaghayegh Sherafatmand
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
-
Phone
+98 61 3222 2922
Fax
-
Email
shershsh@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahnam Askarpoor
Position
Pediatric Surgery Subspecialties
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+61 32222922
Fax
Email
Shahnam-Askarpour@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)