comparison of the prevalence of renal artery stenosis in patients undergoing renal transplantation by end-to-end artery anastomosis with end to side method.
Determination of the prevalence of renal artery stenosis in and end-to-end end-to-end artery bypass grafting technique in renal transplant patients.
Design
Non-random clinical practice with parallel groups and minimization method.
Settings and conduct
The present study is a clinical trial in which the effect of independent renal transplant variables is measured by end-to-side by end-to-end anastomosis method on the dependent variable of renal artery stenosis. The underlying variables of this study are age, sex, employment status, monthly income, health insurance, other diseases such as diabetes, hypertension, and history of transplant rejection.
The kidney transplantation room is located in Afzalipour Hospital and is a doctor's office of the Department of Urology and Nephrology. Patients referring to the kidney transplant of the research community are.
Participants/Inclusion and exclusion criteria
age 18 to 60
Intervention groups
The first group is the end-to-end arterial artery anastomosis
The second group is the end-to-side arterial artery anastomosis
Main outcome variables
renal artery stenosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190125042485N1
Registration date:2019-06-18, 1398/03/28
Registration timing:registered_while_recruiting
Last update:2019-06-18, 1398/03/28
Update count:0
Registration date
2019-06-18, 1398/03/28
Registrant information
Name
Farhad Kharazmi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 6193
Email address
f.kharazmi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the prevalence of renal artery stenosis in patients undergoing renal transplantation by end-to-end artery anastomosis with end to side method.
Public title
comparison of the prevalence of renal artery stenosis in patients undergoing renal transplantation by end-to-end artery anastomosis with end to side method.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years old and suffering from kidney failure. Candidate for transplantation
Exclusion criteria:
Patients' lack of satisfaction in entering the study and performing follow-up after renal transplant surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Not 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 Kerman medical University of Medical Sciences
Street address
Qarni St. Hospital Bahonar Department of Urology
City
Kerman
Province
Kerman
Postal code
7613747181
Approval date
2019-06-14, 1398/03/24
Ethics committee reference number
IR.KMU.REC.1398.134
Health conditions studied
1
Description of health condition studied
transplant renal artery stenosis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Kidney artery stenosis calculated by Doppler ultrasonography of the renal artery and determining the number of RI and PSV
Timepoint
6 months after renal transplant
Method of measurement
Doppler ultrasonography of the renal artery and determining the number of RI and PSV
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Anastomosis of the renal artery to the end of the internal iliac artery receptor (end to end)
Category
Treatment - Surgery
2
Description
Intervention group: Anastomosis of the kidney artery to the side of the external iliac receptor artery (end to side)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipor hospital Kerman
Full name of responsible person
Farhad Kharazmi
Street address
Department of Urology, Bahonar Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618834388
Phone
+98 34 3211 6193
Email
farhadkharazmi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abas Pardakhti
Street address
Imam Khomeini Highway (RA), next to Shahid Bahonar University, Afzalipour Medical Education Center
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
farhadkharazmi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Farhad Kharazmi
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No4,keshavarz Blvd,kerman Town
City
Kerman
Province
Kerman
Postal code
7618834388
Phone
+98 34 3211 6193
Fax
Email
F.kharazmi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farhad Kharazmi
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No4,keshavarz Blvd,kerman Town
City
Kerman
Province
Kerman
Postal code
7618834388
Phone
+98 34 3211 6193
Fax
Email
F.kharazmi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farhad Kharazmi
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No4,keshavarz Blvd,kerman Town
City
Kerman
Province
Kerman
Postal code
7618834388
Phone
+98 34 3211 6193
Fax
Email
F.kharazmi@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available