Comparison between complications of surgical repair of indirect inguinal hernia by Lichtenstein and Read-rives methods in the 20-40 year-old patients referred to Hamadan Besat Hospital
Aim of study: To Compare complications of surgical repair of indirect inguinal hernia by Lichtenstein and Read-rives methods.
Design: Randomized, Not blinded, single cener.
Study population: Twenty to forty year-old patients with indirect inguinal hernia referred to Hamadan Besat Hospital since 21 November 2012 until 19 March 2013(for 4 months).
Inclusion Criteria: Twenty to forty year-old patients with unilateral indirect inguinal hernia.
Exclusion Criteria: Mortality during and after the surgery, hematoma and infection of the surgery site.
Volume: 86 patients.
Interventions: Lichtenstein and Read-rives surgery methods.
Time of intervention: During the procedure.
Outcomes: operation time, hospital stay, postsurgical pain in two days, one week and three months after surgery and the recurrence of hernia in 6 months after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311018729N6
Registration date:2014-08-19, 1393/05/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-19, 1393/05/28
Registrant information
Name
Seyed Mohammad Reza Javadi
Name of organization / entity
Hamadan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0061
Email address
mr.javadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
-
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between complications of surgical repair of indirect inguinal hernia by Lichtenstein and Read-rives methods in the 20-40 year-old patients referred to Hamadan Besat Hospital
Public title
Comparison between two surgical methods of inguinal hernia repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:. Twenty to forty years-old patients with unilateral indirect inguinal hernia.
Exclusion Criteria: Mortality during and after the surgery, hematoma and infection of the surgery site.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
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
Ethics committee of Hamadan University of Medical Sciences.
Street address
Hamadan University of Medical Sciences, Mahdie Blvd
City
Hamadan
Postal code
65178
Approval date
2012-11-19, 1391/08/29
Ethics committee reference number
160/35/9/3043/پ/د
Health conditions studied
1
Description of health condition studied
Unilateral Inguinal Hernia
ICD-10 code
k40.9
ICD-10 code description
Inguinal hernia (unilateral) NOS
Primary outcomes
1
Description
Duration of operation
Timepoint
After operation
Method of measurement
Minute-Clock-Patient case
2
Description
Hospital stay
Timepoint
After discharge
Method of measurement
Day-Patient case
3
Description
Pain after operation
Timepoint
2 days, 1 week and 3 months after surgery
Method of measurement
Number-Pain score
4
Description
Recurrence after surgery
Timepoint
6 months after surgery
Method of measurement
Surgeon idea-Physical exam
Secondary outcomes
empty
Intervention groups
1
Description
Repair of hernia by Read-Rives method in case group1
Category
Treatment - Surgery
2
Description
Repair of hernia by Lichtenstein method in case group2
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Seyed Mohammad Reza Javadi
Street address
Besat Hospital, Ayatollah Motahari Blvd
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research,Hamadan University of Medical Sciences
Full name of responsible person
Dr.Saeed bashirian
Street address
Vice Chancellor for Research,Hamadan University of Medical Sciences, Mahdie Blvd
City
Hamadan
Grant name
ندارد
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research,Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Hesam Amini
Position
Resident of general Surgery
Other areas of specialty/work
Street address
Besat Hospital, Ayatollah Motahari Blvd
City
Hamadan
Postal code
Phone
+98 81 3264 0061
Fax
ندارد
Email
un120000@yahoo.com
Web page address
ندارد
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Javadi
Position
General surgeon
Other areas of specialty/work
Street address
Besat Hospital, Ayatollah Motahari Blvd
City
Hamadan
Postal code
Phone
+98 81 3264 0061
Fax
-
Email
Mr.Javadi@umsha.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Hesam Amini
Position
Resident of general surgery
Other areas of specialty/work
Street address
Besat Hospital, Ayatollah Motahari Blvd
City
Hamadan
Postal code
Phone
+98 81 3264 0061
Fax
-
Email
un120000@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)