Comparison of the complications of oblique external flap procedure and mesh for the repair of the channel in inguinal hernia's patients
Design
This study is a double-blind randomized clinical trial with a sample size of 50 patients, 25 people in each group (intervention and control). Because it is not possible to blind the surgeon to the intervention, only the participants and the statistical analyzer will be blind to the intervention and outcomes.we randomiz Patients in 2 groups with Rand Excel function software.
Settings and conduct
The intervention will be performed in the operating room of Imam Reza Hospital in Tabriz. The 50 patients selected by simple random sampling using a computer-generated random number table are divided into two treatment groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients with a straight inguinal hernia with a loose canal floor. Exclusion criteria: patients with a history of inguinal hernia surgery; elderly people with weak external oblique fascia; patients with a history of mesh implantation;.
Intervention groups
Intervention group 1: In this intervention, patients with loose inguinal canal floor will be repaired using the oblique external flap.
Intervention group 2: In this intervention, patients with loose inguinal canal floor will be repaired using mesh.
Main outcome variables
The rate of pain postoperative surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211129053215N1
Registration date:2022-03-07, 1400/12/16
Registration timing:registered_while_recruiting
Last update:2022-03-07, 1400/12/16
Update count:0
Registration date
2022-03-07, 1400/12/16
Registrant information
Name
Siyamak Khasteh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3549 8101
Email address
siya.shapke@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-11, 1400/11/22
Expected recruitment end date
2023-02-11, 1401/11/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the complications of oblique external flap procedure and mesh for the repair of the channel in inguinal hernia's patients
Public title
Effect of oblique external flap and mesh on inguinal hernia's patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a straight inguinal hernia with a loose canal floor
Exclusion criteria:
Patients with a history of inguinal hernia surgery
Elderly people with weak external oblique fascia
Patients with a history of mesh implantation
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block method 4 was used to determine the allocation sequence. White envelopes are used to hide the allocation sequence. In this way, each sequence is placed inside a white envelope and the envelopes are arranged side by side and we number the letters to don't be disorganized. For each eligible participant, an envelope will be opened and assigned to the desired group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and analysts of research data will be blind to the type of intervention and outcome. Patients are only aware of approved standard surgical repair, regardless of the type of hernia repair method. Also, because patients' analytical identities will be recorded based on patient numbering and numbering of the type of intervention and consequences, the data analyst will be blinded. patients will be included in the intervention or control group, respectively, and the patient number is in fact the patient's analytical identity. The intervention group is assigned the number 1 and the control group the number 2, and also for the outcomes under study, the numbers 1 to 5 are assigned, respectively.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Azadi Blvd, Resalat Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5173865955
Approval date
2021-04-12, 1400/01/23
Ethics committee reference number
IR.TBZMED.REC.1400.062
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
Pain
Timepoint
One day after surgery, 6 months after surgery, 12 months after surgery
Method of measurement
Interview with the patient
Secondary outcomes
1
Description
Recurrence of hernia
Timepoint
6 months after surgery, 12 months after surgery
Method of measurement
Perform ultrasound
2
Description
Infection of surgery site
Timepoint
6 months after surgery, 12 months after surgery
Method of measurement
Ultrasound
3
Description
Post operative hematoma
Timepoint
During the week after surgery
Method of measurement
Perform ultrasound
4
Description
Feeling of a foreign body at the operation site
Timepoint
Post operative surgery
Method of measurement
Interview with the patient
Intervention groups
1
Description
Intervention group 1: In this intervention, patients with loose inguinal canal floor will be repaired using the oblique external flap.
Category
Treatment - Surgery
2
Description
Intervention group 2: In this intervention, patients with loose inguinal canal floor will be repaired using mesh.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Afshar Zomorrodi
Street address
Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
imamreza@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Akbar Khaleghi
Street address
Daneshah Street
City
Tabriz
Province
East Azarbaijan
Postal code
33364658
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Elham Jahantabi
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Daneshga street
City
Tabriz
Province
East Azarbaijan
Postal code
33364658
Phone
+98 41 3334 7054
Email
zomorrodiaf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshar Zomorrodi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
imamreza@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshar Zomorrodi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
imamreza@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD