Does an anti-reflux ureteral stent offer real benefits for children after endoscopic surgery for upper urinary tract stones? A single-center randomized controlled trial.
Qibo Hu, Hongbo Liu, Wei Ru...
https://pubmed.ncbi.nlm.nih.gov/42249895/Actively Recruiting
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2024-11-12
108
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to compare the effects and complications of anti-reflux ureteral stents with conventional stents in children undergoing surgery for urinary tract stones, known as urolithiasis. The study focuses on pediatric patients treated at the Childrens Hospital affiliated with Zhejiang University School of Medicine. Ureteral stents are important devices used after stone removal surgeries to support the ureter and help urine flow, but they can cause symptoms like urinary infections and pain, affecting childrens quality of life. Anti-reflux stents have special valves designed to prevent urine from flowing backward, potentially reducing these symptoms, but their effectiveness in children has not yet been studied. Participants will be randomly assigned to receive either the LaiKai anti-reflux ureteral stent or the regular LaiKai ureteral stent during their stone surgery. These devices both support the ureter and assist urine drainage, with the anti-reflux version featuring a valve to prevent backward flow. The study includes a triple-blind design to reduce bias. The stents will be placed during surgery, and the effects will be monitored over the following weeks. Children will be followed for two weeks after stent insertion and two weeks after stent removal to assess pain levels, urinary symptoms, stone clearance rates, daily activities, psychological well-being, clinical presentation, and learning impact. Various evaluations, including clinical assessments and questionnaires, will help measure these outcomes. The study seeks to provide insights into how these stents affect recovery and quality of life in pediatric urolithiasis patients.
CONDITIONS
Comparison of Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
A
Aimei Ma
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The Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive either an anti-reflux ureteral stent or a standard ureteral stent following urolithiasis surgery to support urine drainage.
Stent insertion visit and stent removal visit approximately 2 weeks later
Duration - 2 weeks
Participants are monitored for stent-related symptoms including body pain, urinary symptoms, and effects on daily activities and psychological well-being after stent removal.
1 follow-up visit after stent removal
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Qibo Hu, Hongbo Liu, Wei Ru...
https://pubmed.ncbi.nlm.nih.gov/42249895/The Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor