1. Home
  2. Approved trials
  3. » فارسی

Evaluation and comparison of the results of hernioplasty treatment by Totally Extraperitoneal (TEP) technique by spinal anesthesia and general anesthesia

Protocol summary

Study aim
Evaluation and comparison of the results of hernioplasty treatment by Totally Extraperitoneal (TEP) technique by spinal anesthesia and general anesthesia
Design
Clinical trial without control group with parallel, randomized, phase 3 groups on 110 patients A random number table was used for randomization.
Settings and conduct
This study is performed in Al-Zahra Hospital in Isfahan. Patients are randomly divided into two groups. The first group undergoes hernioplasty under spinal anesthesia and the second group undergoes general anesthesia surgery. Pain and complications of surgery are measured and compared between the two groups 1 hour, 3 hours and 6 hours after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of inguinal hernia, patients between 50-60 years, patients with no spinal anesthesia or general anesthesia and laparoscopic surgery, obtaining written consent. Exclusion criteria: Patients who have not referred for follow-up treatment for any reason, Patients who for any reason do not want to continue to cooperate in this project, have a history of cardiovascular disease, history of major abdominal surgery, history of any cancer, defect Safety
Intervention groups
Intervention group 1: Patients in this group undergo TEP hernioplasty by spinal anesthesia. 1 hour, 3 hours and 6 hours after surgery, patients' pain and the duration of surgery and surgical complications in them will be measured and compared. Intervention group 2: Patients in this group undergo TEP hernioplasty by general anesthesia. 1 hour, 3 hours and 6 hours after surgery, patients' pain and the duration of surgery and surgical complications in them will be measured and compared.
Main outcome variables
Pain and complications of surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200217046523N6
Registration date: 2020-12-14, 1399/09/24
Registration timing: prospective

Last update: 2020-12-14, 1399/09/24
Update count: 0
Registration date
2020-12-14, 1399/09/24
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-01-25, 1399/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the results of hernioplasty treatment by Totally Extraperitoneal (TEP) technique by spinal anesthesia and general anesthesia
Public title
Evaluation and comparison of the results of hernioplasty treatment by spinal anesthesia and general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of inguinal hernia Patients between 50-60 years Patients should not be contraindicated for spinal anesthesia or general anesthesia and laparoscopic surgery. Obtaining written consent
Exclusion criteria:
Patients who have not sought follow-up treatment for any reason Patients who for any reason do not want to continue to cooperate in this project History of cardiovascular disease History of major abdominal surgery History of any cancer Immunodeficiency
Age
From 50 years old to 65 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group . The researcher begins to read the numbers in a predetermined manner and the patients are divided.
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 Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۷۸۶۶۵۱۵
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.MUI.MED.REC.1398.066

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
Pain
Timepoint
1 hour, 3 hours and 6 hours after surgery
Method of measurement
Visual Analogue Scale questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Patients in this group undergo TEP hernioplasty by spinal anesthesia. 1 hour, 3 hours and 6 hours after surgery, patients' pain and the duration of surgery and surgical complications in them will be measured and compared.
Category
Treatment - Surgery

2

Description
Intervention group 2: Patients in this group undergo TEP hernioplasty by general anesthesia. 1 hour, 3 hours and 6 hours after surgery, patients' pain and the duration of surgery and surgical complications in them will be measured and compared.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Masoud Sayadi
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@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
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.
Comments
Loading...