A comparative study of the function of the kidney after Endovascular Aneurysm Repair (EVAR) and open surgery in patients with the infra renal abdominal aortic aneurysm
Comparison of renal function after Endovascular Aneurysm Repair (EVAR) and open surgery in patients with the infrarenal Abdominal Aortic Aneurysm
Design
Clinical trial, comparative study with two arm parallel group, without blindness postoperative outcome assessment
Settings and conduct
Comparison of renal function in patients with the infra renal abdominal aortic aneurysm terated with Endovascular Aneurysm Repair (EVAR) and open surgery using RIFLE criteria and GFR done in 4 steps after surgery
Participants/Inclusion and exclusion criteria
Patients with the infra renal abdominal aortic aneurysm
Intervention groups
1_EVAR
2_Open surgery
Main outcome variables
prevention of renal function loss after abdominal aortic aneurysm repair; improving the quality of life after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190617043916N1
Registration date:2019-06-23, 1398/04/02
Registration timing:retrospective
Last update:2019-06-23, 1398/04/02
Update count:0
Registration date
2019-06-23, 1398/04/02
Registrant information
Name
Elham Zaebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 1680
Email address
elham.zaebi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2016-03-20, 1395/01/01
Actual recruitment end date
2019-06-22, 1398/04/01
Trial completion date
2019-06-22, 1398/04/01
Scientific title
A comparative study of the function of the kidney after Endovascular Aneurysm Repair (EVAR) and open surgery in patients with the infra renal abdominal aortic aneurysm
Public title
Renal dysfunction after EVAR and open surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have the infrarenal Aneurysm of Aort
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
133
Actual sample size reached:
50
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 Kermanshah University of Medical Sciences
Street address
Attar Blvd, moallem town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714893486
Approval date
2019-06-12, 1398/03/22
Ethics committee reference number
IR.KUMS.REC.1398.236
Health conditions studied
1
Description of health condition studied
Infra renal abdominal aortic aneurysm
ICD-10 code
171.4
ICD-10 code description
Abdominal aortic aneurysm, without mention of rupture
Primary outcomes
1
Description
Renal dysfunction after EVAR and open surgery in patients with the infrarenal Abdominal Aortic Aneurysm using RIFLE criteria
Timepoint
Calculate the filtration rate immediately after operation.A month later, Six months later, and a year later
Method of measurement
RIFLE CRITERIA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1_EVAR, patients with the infra renal abdominal aortic aneurysm treated with Endovascular Aneurysm Repair. Intervention group: open surgery, patients with the infra renal abdominal aortic aneurysm treated with open endoaneurysmoraphy surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
ImamReza hospital
Full name of responsible person
Ali sorush
Street address
Zakariya Razi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
75333_67427
Phone
+98 83 3427 6300
Fax
+98 83 3427 6300
Email
Irhk@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
Daftarriasat@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Elham Zaebi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Attar Blvd, moallem town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714893486
Phone
+98 83 3427 1680
Email
Elham.zaebi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
MohamadReaza Sobhiyeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
ImamReza hospital
City
Kermanshah
Province
Kermanshah
Postal code
75333_67427
Phone
+98 833427630020
Email
Mreza.Sobhiyeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Elham Zaebi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Attar Blvd, moallem town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714893486
Phone
+98 83 3427 1680
Email
Elham.zaebi@yahoo.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 information is published after non - detection of individuals.
When the data will become available and for how long
After published
To whom data/document is available
Every one
Under which criteria data/document could be used
For trial study
From where data/document is obtainable
MohamadReaza sobhiyeh, Mreza.Sobhiyeh@yahoo.com
What processes are involved for a request to access data/document