Health Condition 1: N119- Chronic tubulo-interstitial nephritis, unspecified
Conditions
Interventions
Intervention1: Group A: Side to side anastomosis (SS) with Ligation of vein distal to anastomosis
Control Intervention1: Group B: End to side anastomosis
Sponsors
AIIMS NEW DELHI
Eligibility
Inclusion criteria
Inclusion criteria: 1. ESRD 2. 18 to 65 years of age, both genders, 3. Brachial artery with normal duplex ultrasound (DUS) parameters, 4. Luminal diameter of vein more than equal to 2 mm confirmed on DUS 5. Patients willing to participate in the study and willing for regular follow up 6. Requiring a native AVF at cubital fossa as a first access 7. A failed distal arteriovenous fistula
Exclusion criteria
Exclusion criteria: 1. History of surgery on vessels at or proximal to antecubital fossa 2. Previous AVF, AV graft at or proximal to the antecubital fossa on the ipsilateral limb 3. Central venous stenosis or occlusion of vein detected on DUS 4. Deep vein thrombosis or arteriopathy 5. Vein diameter 6. Recent cannulation or multiple punctures of vein 2 weeks before creation of AVF 7. Segmental or complete occlusion of vein detected on duplex ultrasonography (preoperative) or intra-operatively detected during patency test (intraoperatively when there is inability to pass 2 mm vascular dilator into the vein and lack of backflow of blood). 8. Peripheral arterial disease: vessels with extensive arterial disease (calcified or atherosclerosis of artery) detected on DUS prior to the surgery. 9. Lower limb AVF 10. Not willing to participate in the study or follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Technical efficacy: Anastomotic time and anastomotic site bleed 2. Functional efficacy of AVF: i. Radiological maturation of AVF • Duplex ultrasonography findings of flow rate: 600 ml/min • Vein diameter: 6mm ii. Clinical maturation of AVF : Functionality and adequacy • Successful cannulation • Repetitive (more than or equal to 3) haemodialysis, and • Adequate (dialysis for 4 hours with adequate flow rate) Timepoint: 1. immediately after the surgery 2. at 2nd and 6th month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total Operative time 2. total intraoperative blood loss 3. Surgical Site Infection 4. Oedema or swelling 5. Pseudoaneurysm or aneurysmal dilatation 6. Steel syndrome 7. Failure of AVF: Thrombosis / ligation of AVF / kidney transplantation / death 8. Intervention or re-surgeryTimepoint: 1. in minutes 2. in millilitre 3. six months 4. six months 5. six months 6. six months 7. six months 8. six months | — |
Countries
India
Contacts
Public ContactBelmin BJ Winston Gysley
All India Institute of Medical Sciences New Delhi
Outcome results
None listed