End-to-side Versus Side-to-side Anastomosis With Distal Vein Ligation for Arteriovenous Fistula Creation
End-to-side Versus Side-to-side Anastomosis With Distal Vein Ligation for Arteriovenous Fistula Creation
End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the
 function and structure of the kidney irreversibly, over months or years.End-stage renal
 disease (ESRD) arises from many heterogeneous disease pathways that alter the function and
 structure of the kidney irreversibly, over months or years. Haemodialysis (HD) is a lifeline
 therapy for patients with ESRD. Our study to compare methods of AVF creation, side to side
 and end to side . This randomized controlled trial .
End-to-side versus side-to-side anastomosis with distal vein ligation for arteriovenous
 fistula creation: A prospective randomized controlled study

 Introduction: Arteriovenous fistula (AVF) is the lifeline for patients with chronic renal
 failure on hemodialysis. The international guidelines recommend patient's referral for access
 replacement 6 months prior to predicted hemodialysis. The sites being preferred for access
 replacement are distal arm AVF, proximal arm AVF, basilic vein transposition or graft
 insertion, respectively (1) Meticulous preoperative assessment and patient selection play
 great role in achieving functioning AVF with long term patency. AVF maintenance always
 requires multi-disciplinary approach, with surgeons, nephrologist, dialysis nurses and the
 patients themselves working hand in hand. Any break in this circle will lead to failure of
 the AVF, and consequently, failure of hemodialysis. Surgical technique is of paramount
 importance for long term patency of AVF. There is an ongoing debate about the best technique
 to do the anastomosis between the artery and the vein; end to side, or side to side. This
 issue was addressed by very few randomized controlled studies (2,3,4).

 Aim of the study: To compare the results of both surgical techniques for creation of
 arteriovenous anastomosis; End vein to side artery (ETS) versus Side vein to side artery
 (STS).

 Patients and Methods

 -  Study location: Study protocol will be submitted for approval by Mansoura medical
 research ethics committee, faculty of medicine, Mansoura University.

 -  Study design: This is Prospective Randomized controlled trials that is going to be
 conducted at in department of vascular surgery Mansoura University Hospitals

 -  Time of study: The study will be conducted during the year 2017-2019.

 -  Study population: Study population will be on Patients referred to Vascular surgery
 department for creation of Hemodialysis access. Patients will be advised to undergo
 elective surgery for AVF once their renal Glomerular Filtration Rate Estimated (eGFR) is
 less than 15 ml/min.

 -  Inclusion criteria: All renal failure patients requiring creation of arm AVF, including
 distal Radio-cephalic, Ulno-basilic, proximal brachio-cephalic or brachio-basilic
 configurations

 -  Exclusion criteria: Revision AVF, Synthetic graft AVF or lower limb AVF, Patients with
 absent distal pulses and chronic ischemia of the upper limb and Recent cannulation of
 puncture of the vein within 2 weeks before its use in AVF creation.

 -  Primary End Point: Primary patency of Arterio-venous Fistula and Functional Maturation,
 ready fistula for cannulation, vein length at least 10 cm, diameter more than 6 mm,
 depth not more than 6 mm and ability of the access to deliver a flow rate 350 to
 400ml/min and maintain dialysis for 4 hours.

 -  Secondary End Points: Secondary patency, Complication rate failure of maturation,
 bleeding, infection, steel syndrome and aneurysmal dilatation at anastomosis site

 -  Target number for recruitment: 50 patients in each group.

 -  Pre-operative assessment: All patients will undergo clinical assessment as well as
 routine duplex scan for marking of artery and a patent vein suitable for creation of
 AVF, with a minimum vein diameter of 2.5 mm for distal fistula and 3 mm for proximal
 ones.

 -  Method of Randomization: Computer based randomization.

 -  Surgical technique: Patients can have the procedure under general, local anesthetic or
 regional block according to suitability and patients' preference. Mobilization of the
 suitable artery and vein, creation of fistula using 6/0 prolene for anastomosis in
 continuous sutures, either ETS or STS with ligation of the distal end of the vein.
 Arteriotomy size will range from 7 to 10 mm for proximal AVF and from 12 to 15 mm for
 distal AVF, according to the size of the artery.

 -  Sites sharing in the study: Mansoura University Hospital

 -  Post-operative follow-up: Review in clinic on day 6, week 6, months 3 & 6, Duplex scan
 for assessment of flow in 6 weeks, 3 and 6 months.

 Statistical analysis: The data was analyzed using Statistical Package for the Social
 Sciences. The Significant difference between the flow rate volume in both groups (continuous
 variable) will be verified by a two-sample test between the two groups. The data analyzed
 using Cochrane and ANOVA test. Categorical demographic variables were expressed as a
 proportion of the population and compared with a two-tailed Fisher's exact test.
Inclusion Criteria:

 -  All renal failure patients requiring creation of arm AVF

 -  Including distal Radio-cephalic, Ulno-basilic, proximal brachio-cephalic or
 brachio-basilic configurations

 Exclusion Criteria:

 -  Revision AVF, Synthetic graft AVF or lower limb AVF.

 -  Patients with absent distal pulses and chronic ischemia of the upper limb.

 -  Recent cannulation of puncture of the vein within 2 weeks before its use in AVF
 creation.