Comparison of two pediatric herniotomy surgeries with and without external oblique fascia in children with inguinal hernia
Design
A simple, randomized, double-blind clinical trial
Settings and conduct
Hernia surgery in Kashani hospital with two methods of opening the fascia and without opening the fascia
Participants/Inclusion and exclusion criteria
Inguinal hernia
Age under 12 years
The patient's parents are satisfied with participating in the study
Children with incarcerated hernia, hydrocele, undescended testicular sliding hernia; Underlying diseases
Intervention groups
The first group of hernia surgery by opening the external oblique muscle fascia
The second group of hernia surgery without opening the external oblique muscle fascia
Main outcome variables
Hernia stick
Complications of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210501051149N1
Registration date:2021-11-22, 1400/09/01
Registration timing:retrospective
Last update:2021-11-22, 1400/09/01
Update count:0
Registration date
2021-11-22, 1400/09/01
Registrant information
Name
Hossein Tarverdizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3224 5556
Email address
htarverdizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
2020-04-18, 1399/01/30
Actual recruitment end date
2020-07-10, 1399/04/20
Trial completion date
2021-03-19, 1399/12/29
Scientific title
Comparison of two methods of pediatric herniotomy surgery with and without opening external oblique fascia in Children with inguinal hernia
Public title
Comparison of two methods of pediatric herniotomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inguinal hernia
age<12
Exclusion criteria:
Incarcerated hernia
Parental dissatisfaction
Age
To 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
74
Actual sample size reached:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization and color cards
Two cards with different colors were placed in front of the patient and the patient chose one. Each color belonged to one of the two groups
The patient information form was also kept by the doctor's secretary and the doctor and the researcher did not know about it.
Blinding (investigator's opinion)
Double blinded
Blinding description
2 cards with different colors are placed in front of the patient and the patient chooses one. Each color belongs to one of 2 groups. Also, the patient information form is kept by the doctor's secretary and the doctor and the researcher do not know about it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Ayatollah Kashani Hospital،Nurse St.,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854469
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.SKUMS.REC.1398.244
Health conditions studied
1
Description of health condition studied
Pediatric inguinal hernia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Complications of pediatric inguinal hernia surgery
Timepoint
Day 3,7,30 postoperatively
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Pediatric inguinal hernia surgery in two ways by opening the external oblique muscle fascia and without opening the external oblique muscle
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital in Shahrekord
Full name of responsible person
Hossein Tarverdizadeh
Street address
Nurse St., Ayatollah Kashani Hospital
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854469
Phone
+98 38 3226 4832
Email
htarverdizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Mehraban Sadeghi
Street address
Nurse St., Ayatollah Kashani Hospital
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854469
Phone
+98 38 3226 4832
Email
htarverdizadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Hossein Tarverdizadeh
Position
General Surgery Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Nurse St., Ayatollah Kashani Hospital
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854469
Phone
+98 38 3226 4832
Email
htarverdizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Hossein Tarverdizadeh
Position
General Surgery Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Nurse St., Ayatollah Kashani Hospital
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854469
Phone
+98 38 3226 4832
Email
htarverdizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Hossein Tarverdizadeh
Position
General Surgery Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Nurse St., Ayatollah Kashani Hospital
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815854469
Phone
+98 38 3226 4832
Email
htarverdizadeh@gmail.com
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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data includes the results of a share-sharing survey
When the data will become available and for how long
Start of access period one year after publication
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Statistical analysis and research results
From where data/document is obtainable
Shahrekord Medical University
What processes are involved for a request to access data/document
Sending a request to the Vice Chancellor for Research of Shahrekord University of Medical Sciences