Evaluation of using fibrin glue in Mesh Fixation in comparison with suture fixation for inguinal Hernia repairment by Liechtenstein method to reduce complication
Evaluation of using fibrin glue in Mesh Fixation in comparison with suture fixation to reduce complication in inguinal Hernia repairment by Liechtenstein method
Design
120 patients with inguinal hernia entered this single blinded clinical trial from August 2018 and followed until six month. After examining the patients considering the inclusion and exclusion criteria, 20 patients were excluded. The remaining 100 patients were randomly divided into two groups of 50. The mesh was fixed by fibrin glue in first group, and by suture in another group .
Settings and conduct
This single blind clinical trial study was performed on patients with inguinal hernia referred to Shahid Beheshti and Ayatollah Rouhani hospitals in Babol. In this study, the analyzer was not informed about the method of mesh fixing, and the way that data was encoded.
Participants/Inclusion and exclusion criteria
patients aged 18 to 80 years old, unilateral or bilateral inguinal hernia, and patients with Liechtenstein Hernioplasty included in this study.
patients excluded if they have known femoral hernia, large scrotal hernia, emergency operation for strangulated hernia, recurrent hernia, allergy to Bovin Aprotinin, and if they refused to be part of this study.
Intervention groups
All patients underwent Lichtenstein hernioplasty. The mesh was fixed by fibrin glue in Intervention group, and in the control group by suture.
Main outcome variables
Pain; recurrence of inguinal hernia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171213037857N3
Registration date:2019-04-25, 1398/02/05
Registration timing:retrospective
Last update:2019-04-25, 1398/02/05
Update count:0
Registration date
2019-04-25, 1398/02/05
Registrant information
Name
Ali Zahedian Tijeneki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
a.zahedian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2019-02-20, 1397/12/01
Trial completion date
2019-02-20, 1397/12/01
Scientific title
Evaluation of using fibrin glue in Mesh Fixation in comparison with suture fixation for inguinal Hernia repairment by Liechtenstein method to reduce complication
Public title
result of mesh fixation methods in groin hernia repairment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 18 to 80 years
unilateral or bilateral inguinal hernia
patients with Liechtenstein Hernioplasty
Exclusion criteria:
known femoral hernia
large scrotal hernia
emergency operation for strangulated hernia
recurrent hernia
allergy to Bovin Aprotinin
patient refusal
Age
From 18 years old to 80 years old
Gender
Both
Phase
4
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study patients were randomly divided into two groups of 50 individuals by simple random allocation using the table of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Person who examine the outcomes of patients was not aware of type of the surgery and the grouping of patients and only received the patients' names. The analyzer also received encoded data and did not know how patients were grouped.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrooz Street, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.097
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
Patient pain assessment was performed 7 days, one month and 6 months after Herniorrhaphy surgery.
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Recurrence of inguinal hernia
Timepoint
Evaluation of inguinal hernia recurrences was performed one month and 6 months after Herniorrhaphy surgery
Method of measurement
clinical examination
Intervention groups
1
Description
Intervention group: mesh fixation with fibrin glue in inguinal hernia repairement
Category
Treatment - Surgery
2
Description
Control group: mesh fixation with suture in inguinal hernia repairement
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti and Ayatollah Rohani Hospitals in Babol
Full name of responsible person
Ali Zahedian Tajenaki
Street address
Ganjafrooz Street, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
a.zahedian@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Zahedian Tajenaki
Street address
Ganjafrooz Street, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
a.zahedian@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Chancellor for Research, School of Medicine, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Ali Zahedian Tajenaki
Position
Assistant Professor in Department of Surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ganjafrouz street, babol university of medical science
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
a.zahedian@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Zahedian Tajenaki
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ganjafrouz street, babol university of medical science
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
a.zahedian@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Zahedian Tajenaki
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ganjafrouz street, babol university of medical science
City
babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
a.zahedian@mubabol.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
In this study, all clinical and demographic data are encoded in SPSS software for sharing.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Doctors and people working in academic institutions related to medical sciences
Under which criteria data/document could be used
Use of this research data will be permitted in meta-analysis studies
From where data/document is obtainable
Contact: Alizahed20@yahoo.com, to receive the data
What processes are involved for a request to access data/document
The applicant will be contacted within 48 hours, and if the academic and employment records of the research environment are properly submitted, research data will be provided to the applicant upon confirmation of the identity of the originator.