Actively Recruiting

Phase Not Applicable
Age: 0Years - 18Years
All Genders
ID06569173

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

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

On this page

AI-Summary

What this Trial Is About

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 Children's 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 children's 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

Brief Title

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

Who Can Participate

Age: 0Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A confirmed diagnosis of urinary tract stones by CT scan with indications for stone removal surgery including ureteroscopic lithotripsy, percutaneous nephrolithotomy, laparoscopic or open stone extraction, with or without robotic assistance.
  • Age less than 18 years old.
  • Signed informed consent by parents for preschool children; for school-age children, consent by both parents and the child.
Not Eligible

You will not qualify if you...

  • History of recurrent bladder irritative symptoms or urinary tract infections.
  • Severe kidney problems, solitary kidney, or other serious health conditions making participation unsuitable.
  • Stent placement surgery within the past 3 months.
  • Recent use of medications that may affect study results, such as solifenacin.
  • Stent removal surgery performed at an external medical facility.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 1 location

1

Children's hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310052

Actively Recruiting

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Research Team

A

Aimei Ma

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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