Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Aim 2: Intraoperative variables
研究概览
简要总结
The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.
详细描述
In this study we aim to compare two variations of the miniaturized percutaneous nephrolithotomy (Mini-PCNL) procedure which are both used for the surgical treatment of kidney stones. This procedure involves accessing the kidney via a small temporary tract that is placed through the patient's back during surgery. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.
Two procedure types will be investigated:
- Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) vacuum-assisted tube with suction capability to assess the kidney and extract the stone.
- Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) standard tube to assess the kidney and extract the stone.
Approximately 90 people will take part in this study at Cleveland Clinic. The duration of the study will include the day of the surgery and following hospital stay until postoperative follow-up appointment with the surgeon approximately 4-6 weeks after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 with planned prone mini-PCNL and a preoperative NCCT
- •Primary stone size: 10-25 mm
- •Pre-existing indwelling nephrostomy tube or ureteral stent permitted
- •Age: ≥ 18 years old
- •Gender: all
- •Ethnicity: all
- •Capable of giving informed consent
- •Capable and willing to fulfill requirements of the study
排除标准
- •Anticoagulated or history of coagulopathy
- •Congenital renal anomalies
- •Prior ipsilateral upper urinary tract reconstructive procedures
- •Conversion to open procedure
- •Multiple access tracts
- •Inability to give informed consent or unable to meet requirements of the study for any reason
研究组 & 干预措施
vacuum-assisted sheath
干预措施: vacuum assisted sheath (Device)
passive suction via conventional sheath
干预措施: passive suction via conventional sheath (Device)
结局指标
主要结局
Aim 2: Intraoperative variables
时间窗: 3-7 days
Patients with positive cultures will be treated with appropriate pre-operative antibiotics between 3 to 7 days depending on symptoms. Antibiotics on day of surgery will be selected according to their last pre-operative urine culture which is our standard of care for patients undergoing PCNL
Aim 3: Post-operative Outcomes and Complications
时间窗: 1 day
Post-operative pain scores will be evaluated using a visual analogue scale (VAS) in the post-anesthesia care unit (PACU) and on postoperative day 1. The questionnaire may be filled out on a paper survey or an electronic REDCap survey sent via email. An electronic VAS has shown to be reliable and interchangeable with a paper VAS
Aim 1: Stone free rate
时间窗: 6 weeks
The primary outcome of SFR will be measured using conventional follow up of post-operative NCCT at 6 weeks. NCCT provides the most definitive assessment for post-operative stone burden and allows assessment of radiolucent stones when compared to ultrasound or abdominal x-ray
次要结局
未报告次要终点