RecruitingNot ApplicableNCT06628765

Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children

Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children: A Single-center Randomized Controlled Trial

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Enrollment

52 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

Urinary Stone

Summary

The single-use digital flexible Ureteroscopy (fURS) is commonly used for the treatment of upper urinary tract stones. The size of the outer diameter of the fURS can affect the safety, efficacy, and medical costs of the treatment. Particularly for children, their ureters are thinner and more tortuous compared to adults, which places higher demands on medical devices. The investigators are interested in determining if the performance of the two different sizes of fURS (6.3 Fr vs. 8.6 Fr) are equivalent. This study will have guiding significance for the selection of upper urinary tract stones surgery in children in the future.

Eligibility

Min Age: 0 YearsMax Age: 14 Years

Inclusion Criteria3

Patients scheduled for ureteroscopy and laser lithotripsy for individual renal stones ranging in size from 5 mm to 20 mm in all intrarenal locations (If there are multiple stones present, the total stone burden in cross section should not exceed 20 mm)
Patients \< 14 years
For children younger than 8 years old, the informed consent form is signed by the parents; for children older than 8 years old, the informed consent form is signed by both the parents and the child themselves.

Exclusion Criteria4

Children with uncontrolled urinary tract infections or coagulation disorders and other contraindications for surgery before the operation.
Children with severe renal insufficiency, anatomical or functional solitary kidney, known nephrocalcinosis, and other significant comorbidities that are not suitable for participating in the study.
Children who refuse to participate in this study.
Any other reason that in the opinion of the investigator would make the participant unsuitable for enrollment in the study.

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