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Comparison of complications and recurrence of Liechtenstein and Basini inguinal hernia repair techniques

Protocol summary

Summary
In this prospective clinical trial study,all the patients in Rouhani and Beheshti hospital, who underwent surgery due to unilateral inguinal hernia, during years 2015-2016 were enrolled to study ,after obtaining informed consent, the patient age range in this study is around 18 to 80 years. Exclusion criteria are: patients younger than 18 and older than 80 years, patients with history of hernia surgery, bilateral inguinal hernia, incarcerated hernia and femoral hernia. The patients were randomly divided into two different groups: the first group are patients who underwent surgery by Liechtenstein technique with mesh, and in the second group, repaired has been done by basini technique. At first, all the patient refer for hernia repair surgery, and all of them will operate by a specified surgical team. Postoperative pain intensity is evaluated based on Visual Analog Scale(VAS). After surgery and hospital discharge patients were followed for 6 month to 1 year with phone call and questionnaire through clinic.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016042627608N1
Registration date: 2017-02-27, 1395/12/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-27, 1395/12/09
Registrant information
Name
Emadoddin Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
emoudi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of complications and recurrence of Liechtenstein and Basini inguinal hernia repair techniques
Public title
Comparison of complications and recurrence of Liechtenstein and Basini inguinal hernia repair techniques
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: unilateral inguinal hernia; candidate for for surgery under general or spinal anesthesia Exclusion criteria: Age less than 18 and older than 80 years, history of hernia surgery, bilateral inguinal hernia, incarcerated hernia, femoral hernia; increased intraabdominal pressure due to ascites
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol-Iran
City
Babol
Postal code
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
MUBABOL.REC.1394.213

Health conditions studied

1

Description of health condition studied
Surgical Wound Complications
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure, not elsewhere classified

Primary outcomes

1

Description
Surgical Wound Complications
Timepoint
Three months, six months to a year after surgery
Method of measurement
Examination

Secondary outcomes

1

Description
Hernia recurrence
Timepoint
3 months, 6 months and one year after surgery
Method of measurement
Examination

2

Description
pain
Timepoint
3 months, 6 months and one year after surgery
Method of measurement
Measurement of pain according to VAS scale

Intervention groups

1

Description
50 patients in the group underwent surgery by Liechtenstein technique
Category
Treatment - Surgery

2

Description
50 patients in the group underwent surgery by basini technique
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Dr. Emadodin Moudi
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol-Iran
City
Babol

2

Recruitment center
Name of recruitment center
Babol Ayatollah Rohani Hospital
Full name of responsible person
Dr. Emadodin Moudi
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol-Iran
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Aliakbar Moghaddamnia
Street address
Babol University of Medical Sciences, University Square,Babol
City
Babol
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 and Technology, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr.Emadouddin Moudi
Position
Assistant Professor
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 3219 7667
Fax
Email
emadmoudi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Emadouddin Moudi
Position
Assistant Professor
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 3219 7667
Fax
Email
emadmoudi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Emadouddin Moudi
Position
Assistant Professor
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 3219 7667
Fax
Email
emadmoudi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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