Comparison of Surgical Outcomes in the Treatment of Renal Stones Larger Than 1 Centimeters Between MPCNL and RIRS: a Single-center, Randomized, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- stone-free rate
研究概览
简要总结
The objective of this research is to investigate the surgical outcomes of minimally invasive percutaneous nephrolithotomy(MPCNL) and retrograde intrarenal surgery (RIRS)for patients with renal stone larger than 1cm.
详细描述
It is pointed out that there is the disadvantage of conventional PCNL technique which showed dramatic decrease in Hb and renal damage even though it has some advantages of a short operation time and a high stone-free rate. MPCNL and RIRS has recently been considered as very efficacious methods.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The person who has been diagnosed with renal stone larger than 1cm renal and who has been supposed to undergo MPCNL or RIRS.
- •The person who signed up for participation and agree with intention of clinical test.
排除标准
- •The patient whose medical record has been omitted from database.
- •The patient who has an anatomical abnormality of urinary tract and/or metabolic illness
- •The patient who do not agree with the intention of the clinical study.
研究组 & 干预措施
RIRS (retrograde intrarenal surgery)
Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract
干预措施: RIRS (Device)
MPCNL (mini-perc)
A new technique that reduced the size of percutaneous tract to make renal stone into small pieces.
Patients will be randomized and assigned to each group at the ratio 1:1
干预措施: MPCNL (Device)
结局指标
主要结局
stone-free rate
时间窗: postoperative 1 month
We will check the non-contrast CT scan at postoperative 1month when the patient visit the outpatient department. If the patient does not have any residual stone fragment, it will be reported to 'success.' Otherwise, we will measure the size of each stone of residual fragments.
次要结局
- pain(postoperative 1 day)
- hemoglobin drop(postoperative 1 day)
- occurrence of complications(postoperative 1 day, and the postop 1month at OPD)
- hospital stay(postoperative 1 month)
研究者
Hyeon Jeong
associate professor
Seoul National University Hospital