Comparative study on the efficacy of flexion and non-flexin graft in dialysis patients during a six-month follow-up period
Design
The study is a clinical trial with parallel groups. Patients are those who need long-term dialysis. Fifty patients were selected by convenience sampling method and then randomly divided into two groups. Flexin and non-flexin grafts were included in this trial. Intervention groups are parallel and cannot be blinded.
Settings and conduct
Location: Kermanshah Imam Reza Hospital Dialysis Center
Implementation: Evaluation of patients with postoperative hematoma by clinical examination
Graft Function with Clinical Examination and Color Doppler Ultrasound
Infection with clinical examination
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent and no previous history of intravenous arterial fistula.
No history of central venous destruction.
Exclusion criteria: non-cooperation for follow-up
Immune-attenuating drug use
Autoimmune Disease.
Taking an anticoagulant drug.
Antibiotic drug use
Intervention groups
The study is divided into two groups:
Group 1: There are people who use flexin graft
Group 2: There are people who use non-flexin graft
Main outcome variables
Central venous destruction rate
The fastest time to dialysis
Graft stenosis
Infection rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180223038837N3
Registration date:2019-11-10, 1398/08/19
Registration timing:prospective
Last update:2019-11-10, 1398/08/19
Update count:0
Registration date
2019-11-10, 1398/08/19
Registrant information
Name
Mohammad Reza Sobhiyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6333
Email address
mohammadreza.sobhieh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-20, 1398/08/29
Expected recruitment end date
2020-04-21, 1399/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the efficacy of flexion and non-flexin graft in dialysis patients during a six-month follow-up period
Public title
Comparative study on the efficacy of flexion and non-flexin graft in dialysis patients during a six-month follow-up period
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written and informed patient satisfaction
No previous history of central venous destruction
No previous history of graft for dialysis
Exclusion criteria:
Failure to cooperate for follow-up
Immune-attenuating drug use
Autoimmune disease
Taking anti-coagulants
Taking antibiotics
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
First, a list of four random permutation blocks consisting of permutations of the letters B and A, for example AB and BA, was prepared by the statistical consultant using PAFF software. One person outside the selection researchers (operating room personnel) and qualified people are divided into groups
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
Imam reza hospital, parstar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Approval date
2019-08-16, 1398/05/25
Ethics committee reference number
IR.KUMS.REC.1398.532
Health conditions studied
1
Description of health condition studied
Patients in need of dialysis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stenosis after graft insertion
Timepoint
One month after graft placement, three months after graft placement, six months after graft placement
Method of measurement
Color Doppler Ultrasound
2
Description
pseudoaneurism
Timepoint
One month after graft placement, three months after graft placement, six months after graft placement
Method of measurement
Examination and ultrasound
Secondary outcomes
1
Description
Central vein destruction
Timepoint
One month after graft placement, three months after graft placement, six months after graft placement
Method of measurement
Color Doppler Ultrasound
2
Description
infection rate
Timepoint
One month after graft placement, three months after graft placement, six months after graft placement
Method of measurement
examination
Intervention groups
1
Description
Intervention group: In this group, the selected patients are transferred to the operating room. The procedure is determined on the arm and after washing the operation site, local anesthesia is injected into the ante cobital area and the axillary region and then the skin is cut. The subcutaneous is dissected and brachial and axillary vessels are exposed. Flexin graft is then anastomosis between brachial artery and axillary vein.
Category
Treatment - Devices
2
Description
Control group: In this group, the selected patients are transferred to the operating room. The procedure is determined on the arm and after washing the operation site, local anesthesia is injected into the ante cobital area and the axillary region and then the skin is cut. The subcutaneous is dissected and brachial and axillary vessels are exposed. The jotec graft is then anastomotic between the brachial artery and the axillary vein.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohammadreza sobhieh
Street address
parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3427 6333
Email
mreza.sobhiyeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
parstar blvd
City
kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3837 0541
Email
Farid_n32@yahoo.com
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
Mohammad Reza Sobhiyeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Parstar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 912 183 7405
Email
Mreza.sobhiyeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Reza Sobhiyeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3427 6333
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
Behzad Soleimani
Position
Resident of Surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Parstar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3427 6333
Email
Drbehzad66@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
in the case of the participant's data file, three months after the publication of the article , and after unidentification of the person, the request can be send by email
When the data will become available and for how long
Three months after the article is published, it is possible to send it by email.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Mention the author's name in the extracted article. In this case, any statistical analysis is permitted.
From where data/document is obtainable
By email with Dr. Mohammad Reza Sobhyeh
Mreza.sobhiyeh@yahoo.com
What processes are involved for a request to access data/document
Up to one week after receiving the email, the requested documentation will be sent