Usually the mesh is used in inguinal hernia repair surgery to strengthen the posterior wall of the inguinal canal. The purpose of this study was to compare the outcomes of primary inguinal hernia repair in two types of mesh fixation.
Methods. Double-blind clinical trial was done in patients with non emergent unilateral primary inguinal hernia who were admitted in Sina hospital, Tehran, Iran at 2012-13. The patients were randomly divided into two groups: propylene and Progrip mesh were used in the first and second groups, respectively. All therapeutic interventions expect of mesh kind were similar in both groups before and after surgery. Foreign body sensation, stiffness and numbness in the groin, hernia recurrence, duration of hospital stay and return to normal function, 1, 3, 6 and 12 months after surgery were compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050811560N8
Registration date:2014-05-11, 1393/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-11, 1393/02/21
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
tayebramim@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tehran University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison treatment outcome of surgical repair in primary inguinal hernia with conventional and sutureless mesh
Public title
Comparison treatment outcomes use of two types of mesh in inguinal hernia repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-80 years old; non emergent unilateral primary inguinal hernia.
Exclusion criteria: drug abusers; pregnancy; history of Diabetes mellitus; history of uncontrolled hypertension; history of psychological disorders and use of psychoactive drugs.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical sciences, Ghods st, Keshavarz blv.
City
Tehran
Postal code
6652418542
Approval date
2012-12-27, 1391/10/07
Ethics committee reference number
113-124-د-91
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
1-3-6-12 months after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Hernia recurrence
Timepoint
1-3-6-12 months after surgery
Method of measurement
Physical Examination
Intervention groups
1
Description
Inguinal hernia repair with propylene mesh
Category
Treatment - Surgery
2
Description
Inguinal hernia repair with progrip mesh
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Tayeb Ramim
Street address
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research,Tehran University of Medical Sciences
Full name of responsible person
Dr. Masood Younesian
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research,Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Sina trauma and Surgery Research Center
Full name of responsible person
Tayeb Ramim
Position
Research Assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
Email
tayebramim@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina trauma and Surgery Research Center
Full name of responsible person
Tayeb Ramim
Position
Research Assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
tayebramim@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sina trauma and Surgery Research Center
Full name of responsible person
Tayeb Ramim
Position
Research Assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
tayebramim@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)