RecruitingNot ApplicableNCT06569173

Comparison of Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis

Comparison of the Drainage/Anti-reflux Effect and Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis


Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Enrollment

108 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 0 YearsMax Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria5

  • 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.

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Interventions

DEVICELaiKai anti-reflux ureteral stent

Ureteral stents are serving to support the ureter and facilitate urine drainage with an anti-reflux valve.

DEVICELaiKai Ureteral Stent

Ureteral stents are serving to support the ureter and facilitate urine drainage.


Locations(1)

Children's hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06569173


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