Comparative analysis of Efficacy of Retrograde Intrarenal Surgery (RIRS) versus Supine Percutaneous Nephrolithotomy (PCNL) for Renal Pelvic Stone 1-2 cm: Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the stone-free rates of retrograde intrarenal surgery versus supine PCNL
研究概览
简要总结
Aim: The aim of this study is to compare SFR of Retrograde Intrarenal Surgery (RIRS) and Supine Percutaneous Nephrolithotomy (PCNL).
Purpose:
-
This study fills a gap in the current literature by directly comparing Retrograde Intrarenal Surgery (RIRS) and Supine Percutaneous Nephrolithotomy (PCNL) for the management of renal pelvic stones measuring 1-2 cm.
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Prior research has primarily concentrated on either of the two techniques individually or in diverse groups of patients, but none have thoroughly examined both treatments within this stone size category using a randomised controlled trial (RCT) design
Research hypothesis: RIRS have no difference in SFR to Supine PCNL for managing renal stones 1-2 cm.
Objectives:
**1.**Primary objective: To compare the stone-free rates achieved by Retrograde Intrarenal Surgery (RIRS) and Supine Percutaneous Nephrolithotomy (PCNL) for treating kidney stones 1-2 cm in maximum diameter
**2.**Secondary objective(s):
1.Average duration each surgery.
2.Fall in haematocrit.
3.VAS for pain.
4.Hospital Stay
- Complications according to Clavien Dindo clasiification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with symptomatic renal stones (causing pain, bleeding, or obstruction) confirmed by imaging (CT scan, ultrasound) 2.Stone size 1-2 cm in diameter on largest dimension 3.Age 18 years or older 4.Able to provide informed consent and willing to undergo randomization.
排除标准
- •1.Pregnancy 2.Active uncontrolled bleeding disorder 3.Uncontrolled systemic infection/urinary tract infection 4.Previous open renal surgery on the affected kidney 5.Physical attributes that significantly hinder access during RIRS or PCNL (e.g., severe ureteral angulation) 6.Inability to tolerate general anaesthesia (for Supine PCNL).
结局指标
主要结局
To compare the stone-free rates of retrograde intrarenal surgery versus supine PCNL
时间窗: 1 month
次要结局
- 1.Average duration each surgery.(2.Fall in haematocrit.)
研究者
Dr Arvind Kumar
AIIMS Patna