Comparison between two inguinal herniotomies with and without incising external oblique aponeurosis
Design
Clinical trial with parallel groups, single-blind study, randomized by heads or tails using healthy coins on at least 80 boy children
Settings and conduct
Male children with inguinal hernia who refer to the pediatric surgery clinic of Imam Ali Alborz Hospital, will be studied. Before the surgery, the surgeon will provide the parents with a complete explanation and after receiving the written consent form from the patient's guardian, the study process will begin. The choice of surgical procedure for each patient will be based on the heads or tails of healthy coin method, which is a random procedure with equal probability of occurrence. After the surgery, the information will be collected using a researcher-made questionnaire that consists of two parts.
single-blind study (heads or tails of coin method)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male children with diagnosed inguinal hernia
exclusion criteria: dissatisfaction to participate in the study
Intervention groups
Both inguinal herniotomy surgeries are currently used by pediatric surgeons.Due to the insufficiency of the studies performed in the field of comparing the two methods in terms of complications and surgery time and the preference of one method over the another method, and considering that in the pediatric surgery references, no report has been presented on the priority of the surgical method. On the other hand, the need to choose a surgical method with fewer complications and a shorter time to benefit the patient, it seems necessary to address this issue.
Main outcome variables
1. Time of surgery
2. Complications: Inguinal nerves damages; Vas defferens damage; Abdominal viscera damage; Surgical hematoma; Wound infection; Scrotal edema; Seroma; Hydrocele
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201123049467N1
Registration date:2020-12-12, 1399/09/22
Registration timing:registered_while_recruiting
Last update:2020-12-12, 1399/09/22
Update count:0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Seyed Ahmad Elahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3250 9256
Email address
elahi84@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between inguinal herniotomies with and without incision of inguinal oblique aponeuresis in male children diagnosed with inguinal hernia
Public title
Comparison between inguinal herniotomies in male children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
male children diagnosed with inguinal hernia
Exclusion criteria:
dissatisfaction to participate in the study
Age
From 1 month old to 170 months old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple
Randomization unit: individual
Randomization tool: heads or tails by healthy coin
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients who entered the study with informed consent are randomly assigned to one of the two groups of inguinal hernia surgery with or without opening the external oblique muscle fascia by the method of heads or tails by a healthy coin.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Office of the Ethics Committee, floor 2, Deputy of Research and Technology, Saffarian Alley, Golshahr St, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2020-10-10, 1399/07/19
Ethics committee reference number
IR.ABZUMS.REC.1399.184
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
Complications during inguinal herniotomy
Timepoint
During surgery
Method of measurement
observation of surgeon
2
Description
The short-term complications after inguinal herniotomy
Timepoint
One week after discharge
Method of measurement
Examination of surgeon
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Male children with inguinal hernia who undergo surgery with incision the external oblique muscle aponeurosis.
Category
Treatment - Surgery
2
Description
Intervention group2: Male children with inguinal hernia who undergo surgery without incision the external oblique muscle aponeurosis.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital, Karaj
Full name of responsible person
Seyed Ahmad Elahi
Street address
Imam Ali Hospital, Vali Asr Ave, Esteghlal Blvd, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3256 2358
Fax
+98 26 3254 7128
Email
emamali@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mohammad Noori Sepehr
Street address
Deputy of Research and Technology, Saffarian Alley, Golshahr St, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Seyed Ahmad Elahi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam Ali Hospital,Vali Asr Ave, Esteghlal Blvd, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7575
Fax
+98 26 3254 7128
Email
emamali@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Seyed Ahmad Elahi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam Ali Hospital, Vali Asr Ave, Esteghlal Blvd, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7575
Fax
+98 26 3254 7128
Email
emamali@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Seyed Ahmad Elahi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam Ali Hospital, Vali Asr Ave, Esteghlal Blvd, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7575
Fax
+98 26 3254 7128
Email
emamali@abzums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Medical students and pediatric surgeons if they have a similar study in other medical centers
From where data/document is obtainable
Seyed Ahmad Elahi
Imam Ali Alborz Hospital
Elahi84@gmail.com
What processes are involved for a request to access data/document
The applicant must send his/her request to the mentioned e-mail address and the data files will be provided to him/her within up to one month.