Aim of study: Comparison of inguinal hernia recurrence rate in surgery by Liechtenstein method with bassini method with mesh embedded. In a prospective clinical trial study, patients aged from 18 to 70 years who underwent unilateral inguinal hernia surgery at Velayat and Rajaee hospitals of Qazvin during years of 2015-2016, are entered to the study after obtaining informed consent. Exclusion criteria are as patients with history of hernia surgery, bilateral inguinal hernia, incarcerated hernia and femoral hernia. The patients are randomly (using closed envelopes and choose A or B cards) divided into two groups: the first group is underwent surgery by Liechtenstein technique with mesh; and the second group is repaired by basini technique. All patients refer for the first time for hernia repair surgery, and all of them are operated by a given surgical team. Postoperative pain intensity is evaluated based on Visual Analog Scale (VAS). Patients are followed for inguinal hernia recurrence immediately, 48 hours, 3 month, 6 month and one year after surgery by using phone call and questionnaire through clinic
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052834175N1
Registration date:2017-08-26, 1396/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-26, 1396/06/04
Registrant information
Name
Alireza Mohammadzade
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3376 0620
Email address
amohammadzadeh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2017-06-05, 1396/03/15
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of inguinal hernia recurrence rate in surgery by Liechtenstein method with bassini method with mesh embedded
Public title
Comparison the recurrence of groin hernia surgery by two different surgical method.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: unilateral inguinal hernia; candidate for surgery under general or spinal anesthesia.
Exclusion criteria: patients younger than 18 and older than 70 years; patients with history of hernia surgery; bilateral inguinal hernia; incarcerated hernia and femoral hernia.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethical Comitte of Qazvin University of Medical Sciences
Street address
Qazvin, Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
IR.QUMS.REC.1396.59
Health conditions studied
1
Description of health condition studied
inguinal hernia, Surgical Wound Complications
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia
2
Description of health condition studied
Complications of procedures
ICD-10 code
T81
ICD-10 code description
Complications of procedures, not elsewhere classified
Primary outcomes
1
Description
recurrence of inguinal hernia
Timepoint
48 hour, 3 month, 6 month and one year after surgery
Method of measurement
Examination
Secondary outcomes
1
Description
Surgical wound complications
Timepoint
48 hours, 3 month, 6 month and one year after surgery
Method of measurement
Examination
2
Description
Postoperative inguinal pain
Timepoint
immediately, 48 hours, 3 month, 6 month and one year after surgery
Method of measurement
Measurement of pain according to VAS scal
Intervention groups
1
Description
surgery by Liechtenstein technique
Category
Treatment - Surgery
2
Description
surgery by basini technique
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Street address
City
Qazvin
2
Recruitment center
Name of recruitment center
Rajaee hospital
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Qazvin, Shahid Bahonar Blvd.
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Qazvin University of Medical Sciences