Comparison of complications of three methods of Basini inguinal hernia surgery, Liechtenstein, Reed-Reeves
Design
Clinical trial with three intervention groups, without blinding, non randomized, on 120 patients.
Settings and conduct
in this non randomized clinical trial study, patients who underwent inguinal hernia repair surgery in Baqiyatallah Hospital according to the type of surgery, basin tissue repair method and mesh repair methods including Liechtenstein and Peritoneal and will be compared in terms of postoperative complications such as postoperative pain and postoperative scrotal hematoma and hernia recurrence and postoperative satisfaction.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Indirect inguinal hernia
2. No history of hernia neurasthenia on any side of the affected area
3. Age over 15 years
4 - No underlying disease that causes delay with no tissue repair (use of corticosteroids and weak immune system and chemotherapy)
5. Elective referral
6-BMI <30
7- No history of herniation and the need to place it in the desired position
Intervention groups
Three groups of 40 people
Basini method, 40 Liechtenstein method, 40 peritoneal method (Reed-Reeves)
Main outcome variables
Duration of hernia repair surgery; Duration of hospitalization after surgery; Chronic pain at the operation site; Occurrence of hydrocele after surgery; Occurrence of urinary retention after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210124050126N2
Registration date:2021-05-07, 1400/02/17
Registration timing:registered_while_recruiting
Last update:2021-05-07, 1400/02/17
Update count:0
Registration date
2021-05-07, 1400/02/17
Registrant information
Name
Erfan Ashjaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
dr.erfan.ashjaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2021-05-19, 1400/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results and complications of three surgical procedures: Hingoin Inginal Basini, Liechtenstein, Reed-Reeves
Public title
Comparison of the results and complications of three surgical procedures: Hingoin Inginal Basini, Liechtenstein, Reed-Reeves
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 15 years
BMI <30
Exclusion criteria:
Indirect inguinal hernia
history of herniauraphy to any taste on the affected side
disease's disease causes the tissue to regenerate without remodeling
(Use of corticosteroids and weak immune system and chemotherapy)
history of herniation and the need to place it in the desired position
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
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 Baqiyatallah University of Medical Sciences
Street address
Vanak, TehranTown
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2020-07-18, 1399/04/28
Ethics committee reference number
IR.BMSU.BAQ.REC.1399.026
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
Inguinal hernia recurrence.
Timepoint
6 months after surgery
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Basini method
Category
Treatment - Surgery
2
Description
Intervention group 2: Liechtenstein method
Category
Treatment - Surgery
3
Description
Intervention group 3: Reed reivs method
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Mohamadjavad Babaii
Street address
Tehran. Marzdaran. Next to the tea. No. 29. the unit
City
Tehran
Province
Tehran
Postal code
۱۴۶۴۸۴۷۱۸۹
Phone
+98 21 8825 4372
Email
dr.babaei_md@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohamadjavad Babaii
Street address
Tehran. Marzdaran. Next to the tea. No. 29. Unit 7
City
Tehran
Province
Tehran
Postal code
۱۴۶۴۸۴۷۱۸۹
Phone
+98 21 8825 4372
Email
dr.babaei_md@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohsamadjavad Babaii
Position
General Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Tehran. Marzdaran. Next to the tea. No. 29. Unit 7
City
Tehran
Province
Tehran
Postal code
۱۴۶۴۸۴۷۱۸۹
Phone
009888254372
Email
dr.babaei_md@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohamadjavad Babaii
Position
General Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Tehran. Marzdaran. Next to the tea. No. 29. Unit 7
City
Tehran
Province
Tehran
Postal code
۱۴۶۴۸۴۷۱۸۹
Phone
+98 21 8825 4372
Email
dr.babaei_md@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Erfan Ashjaei
Position
general practioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 9, West BaharanAve., Derakhti Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1468794713
Phone
+98 21 2676 3281
Email
dr.erfan.ashjaei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data in coded format
When the data will become available and for how long
After completing the study
To whom data/document is available
Executors
Under which criteria data/document could be used
At the request of higher authorities to verify the information
From where data/document is obtainable
To the person in charge of the project
What processes are involved for a request to access data/document
Email the person in charge of the project and mention the written request.