Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL Under Ultrasound Control and PCNL Under Fluoroscopic Control in the Treatment of Kidney Stones
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Blood loss as estimated by postoperative decreases in haemoglobin
研究概览
简要总结
Randomized comparison of patient outcomes following fluoroscopic guided PCNL versus ultrasound-guided PCNL.
详细描述
This study is a randomized controlled trial that compares the operative outcomes and complications of fluoroscopic guided-percutaneous nephrolithotomy versus ultrasound-guided PCNL for renal stones. This study will be a prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either PCNL under fluoroscopic guidance or PCNL under ultrasound guidance. Patients will be asked to complete pre-operative, and postoperative quality of life questionnaires, and to allow the collection of one additional vial of blood for measurement of factors associated with inflammation.
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
- Single (Participant)
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
- •Patients planned for PCNL at participating institution
- •Patients of all ethnic backgrounds
- •Stone size over 10 mm in diameter and a density over 900 Hounsfield units
- •Patients with a large calculus in the upper third of the ureter
排除标准
- •Pregnancy
- •infectious disease of the genitals;
- •conditions that violate the configuration of the kidneys (curvature of the spinal column)
- •anomalies in the development of the kidneys with impaired configuration and position of the kidneys (horseshoe kidney, bisque kidney, S-shaped kidney, L-shaped kidney, lumbar dystopia, iliac dystopia, pelvic dystopia)
- •presence of nephrostomy drainage in the target kidney;
- •urethral stricture or other reason leading to the inability to carry out ureteral catheterization;
- •other conditions that are contraindications to surgical treatment, such as uncontrolled diabetes mellitus, acute cardiovascular conditions, liver failure, alcoholism, and drug addiction;
- •patients who are unable to understand the purpose of the study or refuse further follow-up observation and instructions after treatment;
- •patients with a history of mental illness;
- •participation in another research that interferes with this research;
- •acute renal failure;
- •dissecting aortic aneurysm;
- •acute hypertensive encephalopathy;
- •heavy arterial bleeding;
- •myocardial infarction less than six months before enrollment in the study;
- •Stroke less than six months before enrollment in the study;
- •Insufficiency of blood circulation III-IV New York Heart Association class;
- •Severe rhythm and conduction disturbances;
- •Increase in the level of liver transaminases by more than three times;
结局指标
主要结局
Blood loss as estimated by postoperative decreases in haemoglobin
时间窗: Post-operative day 1
次要结局
- Surgical outcomes(6 months)
- Asses the easiness of accessibility of the targeted stone(Intraoperatively)
- The Puncture fluoroscopy screening time(Intraoperatively)