Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss
研究概览
简要总结
Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.
详细描述
This study is a randomized controlled trial which compares the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones. This study will be a multi-institutional, 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 standard PCNL or mini-PCNL, defined as tract sizes of 30 and 16.5 to 18 French respectively. Patients will be asked to complete pre-operative, and post-operative quality of life questionnaires, and to allow collection of one additional vial of blood for measurement of factors associated with inflammation. The participating institutions are academic medical centers in the United States and Canada that are part of the EDGE research consortium.
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 institutions
- •Age ≥ 18 years old
- •Male and female patients
- •Patients of all ethnic backgrounds
- •Stone size 10-20mm
- •Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.
排除标准
- •Conversion to open procedure
- •Multiple access tracts
- •Anticoagulated or history of coagulopathy
- •Preoperative ureteral stent or nephrostomy tube placement
- •Technical problems/impossibility of localizing the stone on the day of intervention
- •Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.
研究组 & 干预措施
Standard PCNL
Patients receive a standard PCNL procedure using a 24 fr tract
干预措施: PCNL (Procedure)
Mini-PCNL
Patients receive a mini-PCNL procedure using a 16 fr tract
干预措施: PCNL (Procedure)
结局指标
主要结局
Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss
时间窗: Post-operative day 1
Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Post-op decreases in hemoglobin
次要结局
- Procalcitonin- Inflammatory Markers(Post operative day 1)
- Surgical outcomes(30 Days)
- Complication Rates(30 Days)
- IL-6 Inflammatory Markers(Post operative day 1)
- Renal Pelvis Pressures(Intraoperative)