1. Home
  2. Approved trials
  3. » فارسی

Comparison between results of ''Lichtenstein'', "Read-Rives" and "MCvay" repair for treatment of unilateral inguinal hernia in patients referring to Arak university of medical science's hospitals

Protocol summary

Study aim
Comparison between results of ''Lichtenstein',' "Read-Rives" and "MCvay" repair for treatment of unilateral inguinal hernia
Design
Three arm parallel groups, randomized clinical trial
Settings and conduct
At first, patients with unilateral inguinal hernia referred to educational hospitals affiliated to Arak University of Medical Sciences and randomly selected by the table of random numbers, will be allocated to three groups (Lichtenstein',' "Read-Rives" and "MCvay"). All patients will receive 1 gr IV cefazolin before surgery. All patients will undergo general or spinal anesthesia, and the skin will be prepared routinely.Then, the steps of the surgery, according to the Liechtenstein, Read rives, and McWay protocols, will be performed in three groups separately. All patients will undergo surgery by a single surgeon (Resident of Surgery). In all patients, cefazolin 1 gr IV will be continued for 24 to 48 hours every 8 hours, and afterwards patients will receive cap. cefalexin 500 milligrams every 6 hours until one week after surgery. All patients in all three groups will undergo postoperative visit on the first day and the first week after surgery.
Participants/Inclusion and exclusion criteria
inclusion criteria: Men between age 18-75 years, affected by unilateral inguinal hernia and without any complication, Having consent for participation in the study Exclusion criteria: Affected by incarcerated, recurrence and bilateral hernia.
Intervention groups
All patients will allocate to three intervention groups (Lichtenstein',' "Read-Rives" and "MCvay").
Main outcome variables
Early postoperative complications: Acute pain, urinary retention, hematoma scrotal, hematoma ulcer, serum and wound infection.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190511043548N1
Registration date: 2019-06-02, 1398/03/12
Registration timing: prospective

Last update: 2019-06-02, 1398/03/12
Update count: 0
Registration date
2019-06-02, 1398/03/12
Registrant information
Name
Mohammad Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 9120
Email address
m4_rezaei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between results of ''Lichtenstein'', "Read-Rives" and "MCvay" repair for treatment of unilateral inguinal hernia in patients referring to Arak university of medical science's hospitals
Public title
Comparison between results of three different repair methods of unilateral inguinal hernia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men between age 18-75 years Affected by unilateral inguinal hernia and without any complication Having consent for participation in the study ( participants must be signed written consent form )
Exclusion criteria:
Affected by incarcerated hernia Affected by recurrence hernia Affected by bilateral hernia MBI≥35 Having concurrent abdominal surgery Steroid therapy Anti-platelet and anti-coagulant therapy Having drug abuse history Having liver cirrhosis Hypersensitivity to Mesh or immune system deficiency
Age
From 18 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to 'Lichtenstein'', "Read-Rives" and "MCvay" groups according to table of random numbers. To use random number table, the researcher will first set the table numbers to read (for example, up, down, left, or right), then numbers will be considered for different groups (for example, taking 00- 48 for intervention A (Liechtenstein method), numbers 49-96for intervention B (Read-Rives method), and numbers 97-144 for group C (Mcvay method). Then the researcher will put his hand on one of the numbers and moves in one of the predefined directions and records the numbers and assigns them to different groups.
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 Arak University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.ARAKMU.REC.1396.36

Health conditions studied

1

Description of health condition studied
Unilateral inguinal hernia
ICD-10 code
K40.9
ICD-10 code description
Unilateral inguinal hernia, without obstruction or gangrene

Primary outcomes

1

Description
Early postoperative complications (Acute pain, urinary retention, hematoma scrotal, hematoma ulcer, serum and wound infection).
Timepoint
All patients in all three groups will undergo postoperative visit on the first day and the first week after surgery.
Method of measurement
Observation and checklist- Pain will measure by 0–10 Numeric Pain Rating Scale.

Secondary outcomes

1

Description
Late postoperative complications (Sensory disturbances, testicular atrophy, testicular pain, inguinal discomfort, pain during exertion, and relapse 9 months after surgery).
Timepoint
9 month after surgery
Method of measurement
Check list and observation- Pain will measure by 0–10 Numeric Pain Rating Scale.

Intervention groups

1

Description
Intervention group: Lichtenstein technique (This method is one of the anterior tension free techniques in inguinal hernia repair that mesh is placed between internal and external oblique muscles and in front of transversalis fascia)
Category
Treatment - Surgery

2

Description
Intervention group: Read-Rives technique (This method is one of the tension free techniques in inguinal hernia repair that mesh is placed under transversalis fascia and on the peritoneum)
Category
Treatment - Surgery

3

Description
Intervention group: MC vay technique (This method is one of inguinal hernia repair techniques that inguinal and femoral defects is repaired with together)
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Educational hospitals' affiliated to Arak university of medical sciences
Full name of responsible person
Miss Khodadadi- Vice Chancellor of Research & Technology
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Vice chancellor for Research and Technology, Payambar-e-Azam Complex, University of Medical Sciences, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Fax
+98 86 3417 3645
Email
research@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/vcr/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mohammad Jafari
Position
ُSurgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Second alley, Iman St., Moallem Sq., Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8714868654
Phone
+98 31 5557 3979
Email
m4_rezaei@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Jafari
Position
Surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Second alley, Iman St., Moallem Sq., Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8714868654
Phone
+98 31 5557 3979
Email
m4_rezaei@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Jafari
Position
Surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Second alley, Iman St., Moallem Sq., Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8714868654
Phone
+98 31 5557 3979
Email
m4_rezaei@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Loading...