Therapeutic outcomes of mesh fixation with suture versus glue in inguinal hernia repair with Lichtenstein method.
Design
Two arm parallel group randomised controlled trial, with blinded patients.40 patients enter the study. Random number table is used for randomization.
Settings and conduct
Forty patients with indirect inguinal hernia who are candidate for Lichtenstein hernioplasty at Imam Hossein Medical Center, Tehran, will enter this randomised controlled, single blind study. Patients will be randomly placed in one of two groups; mesh fixation with N-Hexyl Cyanoacrylate glue group or suture group. Patients are not aware about their group and are blinded. They will be followed up for for 1 year and data will be collected and will be compared.
Participants/Inclusion and exclusion criteria
Patients candidate for indirect inguinal hernioplasty will be included in the study. Exclusion criteria are impossible to follow patients, recurrent hernia, long time use of anti-inflammatory drugs, physical status classification grade 3 and higher according to ASA grading system, addiction to alcohol, drug and opium.
Intervention groups
In Group 1 N-Hexyl cyanoacrylate glue will be used for mesh fixation. In Group 2 or control group suture will be used for mesh fixation.
Therapeutic outcomes of mesh fixation with suture versus glue in inguinal hernia repair with Lichtenstein method
Public title
"Mesh fixation with glue in hernia repair"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with indirect inguinal hernia
Exclusion criteria:
Impossible to follow
Recurrent hernia
Long time use of anti-inflammatory drugs
ASA physical status classification 3 and higher
Addiction to alcohol,drugs,opium
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using a random number table. A mixture of numbers from 1 to 40 is made, and patients entering the study get the next code from the table in order. If the number is below 20 the patient will be assigned to the intervention group, and If it is above 20, he or she will be assigned to the control group. Patients in the control group will be operated with suture and the intervention group with glue.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is unaware that he or she is in the glue or suture group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Evin, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-05-15, 1397/02/25
Ethics committee reference number
IR.SBMU.MSP.REC.1397.276
Health conditions studied
1
Description of health condition studied
Comparing mesh fixation with suture versus glue in Lichtenstein inguinal hernia repair
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
1st, 8th, 24th hour post op then 1 week and 1,3,6,12 months after.
Method of measurement
numeric rating scale(NRS) to assess pain.the patients rate their pain on a defined faces pain rating scale.for example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
2
Description
Recurrence
Timepoint
1week-1,3,6,12 months after surgery.
Method of measurement
Physical examination
3
Description
Infection
Timepoint
1 day-1 week-1 month after surgery
Method of measurement
Observation and physical exam
4
Description
Duration of surgery
Timepoint
Start to the end of anesthesia in the operating room
Method of measurement
Anesthesia sheet time table
5
Description
Duration of hospitalization
Timepoint
Days in hospital from the end of surgery
Method of measurement
The patients file
6
Description
Hematoma
Timepoint
8 hours-1 day-1 week after the surgery
Method of measurement
Physical examination
7
Description
Seroma formation
Timepoint
8 hours-1 day-1 week after the surgery
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with indirect inguinal hernia candidate for Lichtenstein hernioplasty with mesh fixation with cyanoacrylate glue
Category
Treatment - Surgery
2
Description
Control group: patients with indirect inguinal hernia candidate for Lichtenstein hernioplasty with mesh fixation with suture
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Medical Center
Full name of responsible person
Arash Mohammadi Tofigh
Street address
Emam Hossein Medical Center, Shahid Madani st.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
arash_mtofigh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
milad karimian ghadim
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
no. 3, motahari alley,bahonar ave.,niavaran
City
Tehran
Province
Tehran
Postal code
1979836713
Phone
+98 21 2685 4694
Fax
Email
dr.miladkarimian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Mohammadi Tofigh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Madani st, Imam Hossein Medical Center
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 5851
Fax
+98 21 7758 5851
Email
arash_mtofigh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
milad karimian ghadim
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
no. 3, motahari alley,bahonar ave.,niavaran
City
Tehran
Province
Tehran
Postal code
1979836713
Phone
+98 21 2685 4694
Fax
Email
dr.miladkarimian@yahoo.com
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 the data of the patients participating in the study will be shared after the study after concealment of the identities.
When the data will become available and for how long
Data sharing will be possible 6 month after publishing the results.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to continue the study and increase the number of samples and develop the study.
From where data/document is obtainable
Arash Mohammadi Tofigh via email address arash_mtofigh@yahoo.com
What processes are involved for a request to access data/document
Immediately after receiving the request, the applicant's person or institution will be examined and the requested file will be sent within a week