Comparing anti-reflux stents and standard stents in children with kidney stones
Comparison of the Drainage/Anti-reflux Effect and Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
This study is testing if special anti-reflux stents can help children with kidney stones recover better and have fewer complications after surgery compared to regular stents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06569173 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and complications of anti-reflux stents versus conventional stents in pediatric patients undergoing surgery for urolithiasis. Ureteral stents are essential for supporting the ureter and facilitating urine drainage post-surgery, but they can cause complications like urinary tract infections and lumbar pain. The study aims to determine if anti-reflux stents, designed to prevent urine reflux, can reduce these symptoms and improve recovery quality in children. This is the first pediatric study to evaluate the efficacy of anti-reflux stents in this context.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years old with a confirmed diagnosis of urinary tract stones requiring surgical intervention.
Not a fit: Patients with a history of recurrent bladder irritative symptoms or urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative recovery and quality of life for children undergoing urolithiasis surgery.
How similar studies have performed: While adult studies suggest potential benefits of anti-reflux stents, this pediatric approach is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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; 2. Age is less than 18 years old; 3. 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. Exclusion Criteria: 1. A history of recurrent bladder irritative symptoms or urinary tract infections; 2. Severe renal insufficiency, anatomical or functional solitary kidney, and other significant comorbidities that render the child unsuitable for participation in the study; 3. Stent placement surgery within the past 3 months; 4. Recent use of medications that may interfere with the study results, such as solifenacin; 5. Stent removal surgery performed at an external medical facility.
Where this trial is running
Hangzhou, Zhejiang
- Children's hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Hongbo Liu — The Children's Hospital of Zhejiang University School of Medicine
- Study coordinator: Aimei Ma
- Email: maaimei@zju.edu.cn
- Phone: +86 15888864134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.