Does the Positioning in Retrograde Intrarenal Surgery Affect Stone-Free Rates? A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Stone-Free Rate After Retrograde Intrarenal Surgery
研究概览
简要总结
The goal of this clinical trial is to determine whether the surgical position during retrograde intrarenal surgery (RIRS) affects stone-free rates in adults with kidney stones. The main questions it aims to answer are:
- Does the modified lithotomy position result in a higher stone-free rate compared to the standard lithotomy position?
- Are there differences in complication rates between the two surgical positions?
Researchers will compare patients undergoing RIRS in the standard lithotomy position to those in the modified lithotomy position (30-degree Trendelenburg with elevated surgical side) to assess its impact on stone clearance and surgical outcomes.
Participants will:
- Be randomly assigned to one of two surgical positions
- Undergo RIRS with standard surgical procedures
- Have follow-up imaging to assess stone clearance after surgery
This study aims to improve surgical techniques and patient outcomes in kidney stone treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Presence of single or multiple kidney stones, with the largest stone ≤2 cm
- •Age ≥18 years
- •Provided written informed consent to participate in the study
- •Indicated for retrograde intrarenal surgery (RIRS) as a treatment approach
排除标准
- •Severe cardiovascular disease (e.g., heart failure)
- •Congenital kidney anomalies (e.g., horseshoe kidney, ectopic kidney)
- •Concurrent ureteral stones
- •Pregnancy or planning pregnancy
- •History of previous kidney surgery on the same side
- •Active urinary tract infection (UTI)
- •Coagulopathy or use of anticoagulant therapy that cannot be stopped before surgery
研究组 & 干预措施
Standard lithotomy position
In this arm we will use standard lithotomy position as control group.
T-Tilt Lithotomy Position
干预措施: The T-Tilt position (Procedure)
结局指标
主要结局
Stone-Free Rate After Retrograde Intrarenal Surgery
时间窗: 6 weeks post-surgery
The percentage of participants with no residual kidney stones (≤4 mm fragments) on non-contrast computed tomography (CT) at 6 weeks postoperatively.
次要结局
- Postoperative Complication Rate(Within 30 days post-surgery)
研究者
Murat Gulsen
Assistant professor
Ondokuz Mayıs University