To compare the results of two surgical techniques (side to side versus end to side joining of vessels) used for sewing a vein to an artery at the antecubital fossa

Phase 3

Completed

Conditions: Health Condition 1: N119- Chronic tubulo-interstitial nephritis, unspecified

Registration Number: CTRI/2021/06/034165

Lead Sponsor: AIIMS NEW DELHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 61

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

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 < 2.0 mm [detected by preoperative-DUS, or intraoperatively when 2 mm coronary dilator cannot be passed through cephalic vein],

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Technical efficacy: Anastomotic time and anastomotic site bleed <br/ ><br> <br/ ><br>2. Functional efficacy of AVF: <br/ ><br>i. Radiological maturation of AVF <br/ ><br>• Duplex ultrasonography findings of flow rate: 600 ml/min <br/ ><br>• Vein diameter: 6mm <br/ ><br> <br/ ><br>ii. Clinical maturation of AVF : Functionality and adequacy <br/ ><br>• Successful cannulation <br/ ><br>• Repetitive (more than or equal to 3) haemodialysis, and <br/ ><br>• Adequate (dialysis for 4 hours with adequate flow rate) <br/ ><br>Timepoint: 1. immediately after the surgery <br/ ><br> <br/ ><br>2. at 2nd and 6th month <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Total Operative time <br/ ><br>2. total intraoperative blood loss <br/ ><br>3. Surgical Site Infection <br/ ><br>4. Oedema or swelling <br/ ><br>5. Pseudoaneurysm or aneurysmal dilatation <br/ ><br>6. Steel syndrome <br/ ><br>7. Failure of AVF: Thrombosis / ligation of AVF / kidney transplantation / death <br/ ><br>8. Intervention or re-surgeryTimepoint: 1. in minutes <br/ ><br>2. in millilitre <br/ ><br>3. six months <br/ ><br>4. six months <br/ ><br>5. six months <br/ ><br>6. six months <br/ ><br>7. six months <br/ ><br>8. six months