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Comparison of the effect of inguinal hernia repair with Liechtenstein method with progrip mesh compared to prolene mesh in reducing complications

Protocol summary

Study aim
Comparison of the effect of inguinal hernia repair using the progrip mesh on improving the quality of life relative to the prolene mesh and their complications
Design
Two arm parallel group randomised trial.
Settings and conduct
In this study, patients were randomly divided into two groups of 40, based on their inclusion criteria. The first group with progrip mesh and the second group with prolene mesh at the Ayatullah Rohani Babylon Medical Center are going under the hernia repair surgery. The amount of pain is assessed based on the visual scale (VAS) postoperation as well as on possible complications.
Participants/Inclusion and exclusion criteria
inclusion criteria: Unilaterla inguinal hernia, age over 18 years old exclusion criteria: recurrence, bilateral, incarcerated inguinal hernia and femoral hernia
Intervention groups
40 patients as progrip mesh group 40 patients , as prolene mesh group
Main outcome variables
Postoperation pain; postoperation complications (hematoma, infection, urinary retention); life style

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171213037857N1
Registration date: 2018-05-02, 1397/02/12
Registration timing: retrospective

Last update: 2018-05-02, 1397/02/12
Update count: 0
Registration date
2018-05-02, 1397/02/12
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
2017-08-23, 1396/06/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of inguinal hernia repair with Liechtenstein method with progrip mesh compared to prolene mesh in reducing complications
Public title
Comparison of surgical complications of inguinal hernia repair using two mesh types
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
unilateral inguinal hernia age over 18 years old
Exclusion criteria:
recurrent inguinal hernia bilateral inguinal hernia incarcerated inguinal hernia femoral hernia
Age
From 18 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
no
Blinding (investigator's opinion)
Not blinded
Blinding description
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 science
Street address
Ganj Afrouz St. Babol University of medical science
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2017-01-04, 1395/10/15
Ethics committee reference number
MUBABOL.REC.1395.197

Health conditions studied

1

Description of health condition studied
post operative pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
postoperative pain
Timepoint
4 and 8 to 12 hours postoperation
Method of measurement
visual analog scale(VAS)

2

Description
postoperative hematoma
Timepoint
12 and 24 hours postoperation
Method of measurement
physical examination

3

Description
Surgery Site Infection
Timepoint
7 days postoperation
Method of measurement
physical examination

4

Description
postoperation urinary retention
Timepoint
12 to 24 hours postoperation
Method of measurement
interview and physical examination

5

Description
lifestyle
Timepoint
6-12 hours and 24 hours post operation and 6 months later
Method of measurement
EQ-5D-EL health question form

Secondary outcomes

empty

Intervention groups

1

Description
40 people as a Liechtenstein-treated group with progrip mesh
Category
Treatment - Surgery

2

Description
Control group: 40 people as a Liechtenstein-based and prolene-operated surgical group
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rouhani educaional medical center- Babol
Full name of responsible person
Ali zahedian Tijanki
Street address
Ganj Afrouz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8262
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
Reza Ghadimi
Street address
Babol University of Medical Science, Ganjafrouz St.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0558
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Amin Gorjizadeh
Position
General Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Surgery Department, Shahid Beheshti Hospital, Shahid Sargord Ghaemi St. Babol
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6005
Email
agorjizadeh@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Zahedian Tijeneki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Babol University of Medical Sciences, Ganj Afrooz Avenue, Babol, Mazandaran.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3225 6285
Fax
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
Amin Gorjizadeh
Position
General Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Surgery Department, Shahid Beheshti Hospital, Shahid Sargord Ghaemi St. Babol
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6005
Email
agorjizadeh@hotmail.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
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
No - There is not a plan to make this available
Title and more details about the data/document
part of the information
When the data will become available and for how long
one year after publish
To whom data/document is available
researchers
Under which criteria data/document could be used
no more information
From where data/document is obtainable
agorjizadeh@hotmail.com Surgery Department, Shahid Beheshti Hospital, Shahid Sargord Ghasemi St. Babol. 4716681451
What processes are involved for a request to access data/document
sending the request by email or mail evaluation and respond
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