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Recruiting Not applicable

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

NCT06569173 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-08-23
Last updated
2024-11-12

Condition(s) studied

UrolithiasisChild, Only

Investigational drug(s) / intervention(s)

LaiKai anti-reflux ureteral stentLaiKai Ureteral Stent

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

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

Study 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

Sex
ALL
Min age
0 Years
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The effect of stents on body pain — 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.

Trial sites (1)

FacilityCityRegionStatus
Children's hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06569173 on ClinicalTrials.gov ↗ ← All trials in China