Comparison of the Drainage/Anti-reflux Effect and Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The effect of stents on body pain
研究概览
简要总结
The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents.
详细描述
Ureteral stents are crucial adjunctive devices following urolithiasis surgery, serving to support the ureter and facilitate urine drainage. However, the application of these stents can lead to complications such as urinary tract infections, lumbar pain, and bladder irritative symptoms, which significantly impact the quality of life in pediatric patients. Novel designs, such as anti-reflux stents equipped with valves, have been optimized to enhance unidirectional urine flow while effectively preventing retrograde urine flow. It is anticipated that these designs could alleviate symptoms of lumbar pain and urinary tract infections, thereby improving the postoperative recovery quality in children. Current adult studies suggest that anti-reflux stents might reduce urine reflux but may also be associated with significantly stronger urinary symptoms. To date, there have been no pediatric studies reported on the efficacy of anti-reflux stents. The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A definitive diagnosis of urinary tract stones by CT scan, with indications for ureteroscopic lithotripsy (URL), percutaneous nephrolithotomy (PCNL), laparoscopic/open stone extraction with or without robotic assistance, or combined endoscopic lithotripsy, and no contraindications;
- •Age is less than 18 years old;
- •For preschool children, the informed consent form is signed by the parents; for school-age children, the informed consent form is signed by both the parents and the child themselves.
排除标准
- •A history of recurrent bladder irritative symptoms or urinary tract infections;
- •Severe renal insufficiency, anatomical or functional solitary kidney, and other significant comorbidities that render the child unsuitable for participation in the study;
- •Stent placement surgery within the past 3 months;
- •Recent use of medications that may interfere with the study results, such as solifenacin;
- •Stent removal surgery performed at an external medical facility.
结局指标
主要结局
The effect of stents on body pain
时间窗: Two weeks after stents inserting and two weeks after stents removing
Inquire whether the child has experienced body pain, especially lumbar pain after the insert or removal of the stent. If yes, assign a value of 1; if no, assign a value of 0. The higher the score, the worse the stent is in terms of relieving lumbar pain.
次要结局
- The effect of stents on stone-free rate(Two weeks after stents inserting and two weeks after stents removing)
- The effect of stents on urinary symptoms(Two weeks after stents inserting and two weeks after stents removing)
- The effect of stents on daily activities and psychological well-being(Two weeks after stents inserting and two weeks after stents removing)
- The effect of stents on clinical presentation(Two weeks after stents inserting and two weeks after stents removing)
- The effect of the stent on learning(Two weeks after stents inserting and two weeks after stents removing)
研究者
Hongbo Liu
Principal Investigator
The Children's Hospital of Zhejiang University School of Medicine