Evaluation of outcomes and functional results of placement of arteriovenous fistula with no-touch technique and comparison with conventional technique in patients who are candidate for hemodyalisis in Shariati hospital during 2017 to 2018
general goal: evaluation of outcome of an arteriovenous fistula between no touch and conventional technique in patients requiring hemodialysis who are referred to Shariati hospital in 2016-2018
practical goal:
improvement of maturation time and primary patency in arteriovenous fistula in patients who are candidate for hemodialysis
Design
a randomized clinical trial based on a randomization list with parallel formation on 70 cases.
Settings and conduct
this study is conducted in Shariati hospital-Tehran University of Medical Sciences- Iran. the nurse who is responsible for the outcome evaluation is blind about the technique of surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the patients who were referred by nephrologists to vascular surgeons in order to placement of AVF. They had a vein diameter of more than 2 mm in distal and continuous patency of the upper limb.
Exclusion criteria:
1) History of AVF placement
2) venous diameter less than 2 mm in diameter
3) absent venous flow in distal of upper limb
4) 3) systolic blood pressure less than 100 mmHg
5) Intention against participation in the study
Intervention groups
patients who are candidates for placement of arteriovenous fistula as a hemodialysis access. intervention in the case group is the placement of arteriovenous fistula by no-touch technique and it is a conventional technique in control group.
Main outcome variables
evaluation of patency rate of AVF in 2 weeks, 5 weeks and 3 months from the operation; time interval to functional start
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200505047307N1
Registration date:2020-08-23, 1399/06/02
Registration timing:retrospective
Last update:2020-08-23, 1399/06/02
Update count:0
Registration date
2020-08-23, 1399/06/02
Registrant information
Name
Alireza Mirsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2450
Email address
alidiza@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
2017-01-09, 1395/10/20
Actual recruitment end date
2018-12-31, 1397/10/10
Trial completion date
2019-07-01, 1398/04/10
Scientific title
Evaluation of outcomes and functional results of placement of arteriovenous fistula with no-touch technique and comparison with conventional technique in patients who are candidate for hemodyalisis in Shariati hospital during 2017 to 2018
Public title
Evaluation of No-touch technique for placement of arteriovenous fistula in hemodyalisis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who are candidate for routine hemodyalisis
candidates for placement of arteriovenous fistula
patent veins in all the course of it in upper limb
Exclusion criteria:
history of placement of arteriovenous fistula
venous diameter of less or equal to 2 milimeter in ultrasonography
absent blood flow in distal vessels
diastolic blood pressure less than 100 mmHg
intention against participation in the study
Age
From 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization was performed based on the table of random numbers. a specific point was chosen and numbers allocated to cases respectively from the top to the bottom of the table. patients with even numbers allocated to the intervention group (no-touch technique) and patients with odd numbers allocated to the control group (conventional technique).
Blinding (investigator's opinion)
Single blinded
Blinding description
patients are identified and randomized by code. the one who is responsible for collecting the outcome data is unaware of the type of operation that had been performed. the type of operation is known by the therapist who is the researcher as well.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tehran university of Medical Sciences
Street address
tehran university of medical sciences central office, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2017-03-21, 1396/01/01
Ethics committee reference number
ir.tums.medicine.rec.1396.4260
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
primary patency rate
Timepoint
2 and 4 weeks and 3 months after intervention
Method of measurement
based on physical examination
2
Description
time interval to start function
Timepoint
2 and 4 weeks and 3 months then monthly for 6 month
Method of measurement
physical examination and start to successful hemodialysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: placement of arteriovenous fistula by No touch technique. in this technique, the cephalic vein is dissected along with fat and surrounding soft tissue without a saline flush in vein.
Category
Treatment - Surgery
2
Description
Control group: arteriovenous fistula placement by conventional technique is done. the conventional technique consists of periadventitial dissection and saline flush in the vein.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Behnam Molavi
Street address
Shariati Hospital, Jalal ale ahmad highway
City
tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Web page address
https://shariati.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences- deputy of research
Full name of responsible person
Behnam Molavi
Street address
Shariati Hospital, Jalal ale ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Web page address
https://shariati.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences- deputy of research
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
Tehran University of Medical Sciences
Full name of responsible person
Alireza Mirsharifi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shariati Hospital, Jalal Ale ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
alidiza@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Mirsharifi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shariati Hospital, Jalal Ale ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
alidiza@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Mirsharifi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shariati Hospital, Jalal Ale ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
alidiza@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
all related data will be published in an English manuscript
When the data will become available and for how long
after the publication, it will be unlimited
To whom data/document is available
based on the publisher`s policy
Under which criteria data/document could be used
for any scientific nonprofitable purposes
From where data/document is obtainable
to corresponding author through researchgate
What processes are involved for a request to access data/document