Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Functional Maturation of Arterio-venous Fistula
研究概览
简要总结
Randomized controlled study to compare the results of two surgical techniques for AVF creation, including the anchor technique (Group A) and parachute technique (Group B).
The study population will be patients referred to the Vascular surgery department for the 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.
primary outcome: Functional Maturation of Arterio-venous Fistula [ Time Frame: Six Months] 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 of 600ml/min and maintain dialysis for 4 hours.
详细描述
Introduction
Aim of the work To compare the results of two surgical techniques for AVF creation, including the anchor technique (Group A) and parachute technique (Group B).
Patients and the method Study location: We will submit the study protocol for approval by Kafr ElSheikh medical research ethics committee, faculty of medicine, Kafr ElSheikh University.
Study design: Randomized controlled study will be conducted in the department of vascular surgery in Kafr El Sheikh.
Time of study: We started in march 2022.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighteen years of age or older.
- •Need for AVF creation for vascular access for planned hemodialysis (within one year), Including distal - Radio-cephalic, proximal brachio-cephalic configurations.
- •Vein mapping studies completed 2.5-3 mm minimum vein diameter on mapping.
排除标准
- •Ipsilateral proximal venous and arterial occlusion or stenosis
- •systemic or local infection at the site planned for AVF creation.
- •Anticipated inability to keep 30-day post-operative follow-up appointment.
- •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 two weeks before its use in AVF creation.
- •Vasculitis (collagen diseases)
结局指标
主要结局
Functional Maturation of Arterio-venous Fistula
时间窗: 6 months
The suitability of an AVF for successful cannulation for dialysis, ascertained by duplex ultrasound study by measuring vein length at least 10 cm, diameter more than 6 mm, depth for skin not more than 6 mm, and ability of the access to deliver a flow rate of 600ml/min and maintain dialysis for 4 hours.
次要结局
- Complication rate and failure of maturation(Six Months)
研究者
Ahmed Abdullah Yahya Mohamed Fouda
Vascular surgery specialist
Kafrelsheikh University