Comparative evaluation for effect of perforator deep vein ligation in maturation and complications of side to side cubital arteriovenous fistula in kidney dialysis patients.
To determine the effect of perforator deep vein ligation in maturation and complications of side to side cubital arteriovenous fistula in kidney dialysis patients
Design
Randomized clinical trial with parallel control group, double blinded in 44 patients.
Settings and conduct
This randomized controlled clinical trial will be done on hemodialysis patients requires a cubital arteriovenous fistula referring to Mashhad Alavi Hospital in 2020-2021.
Patients with proper conditions according to the randomized table (envelope method) are divided into two groups.The intervention is perforating deep vein ligation. Arteriovenous anastomosis will be brachiocephalic or radiocephalic with 4 to 6 millimeters length.Blindness is not possible for the active researcher in the design due to surgery performance.Patients under study, an active radiologist in the current design, an allocation to the groups and a statistical analyst are unaware from the grouping of patients .
Participants/Inclusion and exclusion criteria
Inclusion criteria:Informed consent. Age>18. Having general conditions for the creation of arteriovenous fistula. No history of hypotension.
exclusion criteria:Dissatisfaction with the patient to continue the study. The absence of appropriate anatomical criteria for an appropriate side to side anastomosis (during surgery). End-side anastomosis based on anatomical criteria during surgery.
Intervention groups
Intervention group: Patients in this group will be subjected to perforator deep vein ligation with silk suture 3.0.
Control group: In the control group, the perforator deep vein is not ligated.
Main outcome variables
Cephalic vein maturation and fitness for hemodialysis using venous color doppler ultrasonography.
Venous hypertension and steal syndrome.
Occurrence of general complications of surgery including infection, seroma and hematoma.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080907001224N2
Registration date:2019-11-24, 1398/09/03
Registration timing:registered_while_recruiting
Last update:2019-11-24, 1398/09/03
Update count:0
Registration date
2019-11-24, 1398/09/03
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
05118525311
Email address
ravarih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation for effect of perforator deep vein ligation in maturation and complications of side to side cubital arteriovenous fistula in kidney dialysis patients.
Public title
evaluation for effect of perforator deep vein ligation in side to side cubital arteriovenous fistula in kidney dialysis patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Age>18
Having general conditions for the creation of arteriovenous fistula
No history of hypotension
Exclusion criteria:
Dissatisfaction with the patient to continue the study
The absence of appropriate anatomical criteria for an appropriate side to side anastomosis. (during surgery)
End-side anastomosis based on anatomical criteria during surgery
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Table of randomized numbers using statistical software.
The envelope method is such that the envelopes are prepared and printed by a member of the surgical team (outside the research team),Random numbers with the help of statistical software inserted inside the envelope. Pocket doors will be closed and its contents are not visible from the outside. First, the purpose of the study is explained to the person who follows the conditions and the person, if desired, signs the informed consent form and removes the envelope and then opens it and, based on the contents of the envelope, enters into the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The statistical analyst will be unaware of the intervention and control groups. Blinding is not feasible for the active researcher in the project due to surgery performance. Patients under study, active radiologist in the current design, allocator to the groups and statistical analyst are unaware of the patient group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad University of Medical Sciences
Street address
Vascular and endovascular research center,Alavi Hospital,Mashhad,emam reza 61
City
Mashhad
Province
Razavi Khorasan
Postal code
9173856693
Approval date
2019-02-26, 1397/12/07
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.760
Health conditions studied
1
Description of health condition studied
Chronic kidney disease, stage 5
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
cephalic vein maturation and Suitability for hemodialysis based on doppler ultrasonography.
Timepoint
1 week, 1 month, 3 months
Method of measurement
Maturation criteria based on the color doppler sonography is :flow >600 milliliter/Minute, cephalic length >10 Centimeters Or Two 4 Centimeters Segments; cephalic diameters>6 millimeters and < 5 millimeters Deep From Skin Surface
2
Description
Venous hypertension
Timepoint
1 week, 1 month, 3 months
Method of measurement
The excessive flow of intravenous retrograde leads to intravenous hypertension, which is accompanied by a change in the color of the blue, edema, dilatation of the veins and the color change of the organ in the physical examination.
3
Description
steal syndrome
Timepoint
1 week, 1 month, 3 months
Method of measurement
Steal syndrome refers to the diversion of arterial flow into another vascular bed, which does not meet the tissue needs of the target organ, and is manifested by symptoms such as pain, weakness, tissue loss and ulcers in the physical examination.
4
Description
General Surgical Complications
Timepoint
1 week, 1 month, 3 months
Method of measurement
Complications such as infection, seroma and hematoma are detected in a physical examination.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will undergo deep vein perforator ligation with silk suture 3.0.
Category
Treatment - Surgery
2
Description
Control group: Patients in this group will not undergo deep vein perforator ligation.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi vascular surgery hospital
Full name of responsible person
Hasan Ravari
Street address
Alavi vascular surgery hospital, Emam Reza street 61, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9173856693
Phone
+98 51 3804 7000
Email
ravarih@mums.ac.ir
2
Recruitment center
Name of recruitment center
Alavi hospital
Full name of responsible person
Hasan Ravari
Street address
Emam Reza 61
City
Mashhad
Province
Razavi Khorasan
Postal code
9173856693
Phone
+98 51 3851 3258
Email
ravarih@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Ravari
Street address
Vascular and endovascular research center, Alavi hospital Emam Reza 61
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Ravari
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular Surgery
Street address
Vascular and endovascular research center, Alavi hospital, Emam Reza 61
City
Mashhad
Province
Razavi Khorasan
Postal code
9173856693
Phone
+98 51 3851 3258
Email
ravarih@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Ravari
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular Surgery
Street address
Vascular and endovascular research center, Alavi hospital, Emam Reza 61
City
Mashhad
Province
Razavi Khorasan
Postal code
9173856693
Phone
+98 51 3851 3258
Email
ravarih@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Ravari
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular Surgery
Street address
Vascular and endovascular research center, Alavi hospital, Emam Reza 61
City
Mashhad
Province
Razavi Khorasan
Postal code
9173856693
Phone
+98 51 3851 3258
Email
ravarih@mums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The whole potential data is published after being unidentifiable.
When the data will become available and for how long
The start of the access period will be 6 months after the publication of the results.
To whom data/document is available
Data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Any analysis on the delivered data is allowed.
From where data/document is obtainable
Access to the study documentation will be possible by contacting the Surgery Research Center at Alavi Hospital.The contact number and address, email and site center are listed in the previous sections
What processes are involved for a request to access data/document
After submitting the request and approval to the Center's research committee, the documentation will be sent to the applicant within approximately 1 month.