Urinary Stone
Conditions
Keywords
Urinary Stone, Flexible Ureteroscopy, Children
Brief 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.
Detailed description
The single-use digital fURS is a sterile, disposable, flexible endoscope. Compared to traditional reusable digital flexible endoscopes, single-use digital fURS has lower maintenance costs, is easier to operate, and effectively avoids cross-infection between patients. With technological advancements, the size of single-use digital fURS has become increasingly slim, making them particularly suitable for children with narrow and tortuous ureters who suffered urinary stones. Currently, the single-use digital fURS used in our unit has an outer diameter of 8.6Fr. For younger children, the success rate of the first insertion of the fURS is still relatively low. When the fURS cannot pass through the ureter, it is necessary to actively dilate the ureter with a balloon in one stage, or passively dilate it with a urethral stent during the procedure to facilitate a second-stage fURS procedure. This not only increases the risk of ureteral injury but also incurs additional medical expenses. Recently, HugeMed Company has launched a single-use digital fURS with an outer diameter of 6.3 Fr, which is currently the thinnest single-use fURS in the world, and its effectiveness and safety have been preliminarily verified in clinical practice. The purpose of this study is to compare the safety and efficacy of the 6.3 Fr fURS (HU30S) and the 8.6 Fr fURS (XFGC-FU-660RC) in the clinical treatment of upper urinary tract stones in children.
Interventions
DEVICE8.6 Fr single-use fURS (XFGC-FU-660RC)
Comparative device
DEVICE6.3 Fr single-use fURS (Hugemed, HU30S)
Device being tested
Sponsors
The Children's Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
0 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The success rate of the first fURS insertion | During the procedure | The first insertion of fURS is successful without the need for balloon dilation or passive dilation with a stent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balloon dilation rate | During the procedure | Due to difficulty in passing the fURS through the ureter, balloon dilation of the ureter is performed during the procedure |
| Pre-placement rate of double-J stents | During the procedure | Due to difficulty in passing the fURS through the ureter, the double-J stent is placed during the surgery to passively dilate the ureter, facilitating a second-stage fURS procedure |
| Surgical duration | During the procedure | From the initiation of fURS insertion to the completion of lithotripsy, the fURS is withdrawn from the body |
| Blood loss | During the procedure | Intraoperative blood loss |
| Ureteral access sheath placement (Yes/No) | During the procedure | Whether a ureteral access sheath is placed during the procedure |
| Postoperative hospital stay | Up to one week postoperatively | Postoperative hospital stay |
| Perioperative complications | Through study completion, up to two months postoperatively | Pain (e.g. dysuria and lumbar pain), Hematuria, Frequency and urgency of urination, Fever |
| Stone-free rate at 4 weeks postoperatively | 4 weeks postoperatively | Stone-free status was evaluated at 4-week and defined as a single residual fragment ≤2 mm |
| Indwelling catheter duration | Three days postoperatively | Indwelling catheter duration postoperatively |
Countries
China
Contacts
Primary ContactAimei Ma
Outcome results
None listed