Efficacy, Self, Ureter Injury, Urolithiasis; Lower Urinary Tract
Conditions
Keywords
Urolithiasis, Ratio of Endoscope-Sheath Diameter, Flexible ureteroscope
Brief summary
Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.
Detailed description
Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.
Interventions
PROCEDUREflexible ureteroscope urolithiasis
Using flexible ureteroscope combine with urethral access sheath to treatment urolithiasis
Sponsors
The First People's Hospital of Fuyang District, Hangzhou City
The Central Hospital of Lishui City
Ningbo No. 1 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
9.0Fr disposable electronic flexible ureteroscope combine with 12Fr distally deflectable ureteral access sheath.
Intervention model description
7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- 1.Patients with kidney stones or upper ureteral stones with a cumulative diameter of less than 3 cm are selected for ureteral soft lens holmium laser lithotripsy. 2.Age 18 to 80 years old, gender unlimited. 3.The subjects have no mental illness or language dysfunction, can understand the situation of the study and can sign informed consent.
Exclusion criteria
* 1.Patients with a history of ureteral stenosis or who have undergone open or laparoscopic ureteral or renal lithotomy. 2.Patients with fever one week before surgery 3.Pregnant women and menstruating patients. 4.Patients with combined systemic disease or inability to tolerate anesthesia. 5.Patients undergoing simultaneous surgery for bilateral upper urinary tract stones. 6.Patients with ureteral stent indwelling before surgery. 7.In patients with severe hydronephrosis, the separation of the renal collecting system is greater than 4 cm. 8.Patients with renal anatomic malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of ureteral access sheath insertion | From enrollment to completion of surgery | Proportion of successful ureteral implantation, success rate = number of successful cases/total number of cases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of surgical complications | 7 days | The occurrence of postoperative fever, urogenic sepsis and septic shock |
| The condition of ureter injury | 24 hours | The ureter was observed at exit of the ureteroscope and graded according to Traxer's proposed grading system. |
| Stone clearance rate | up to 8 weeks. | Residual stones less than 4 mm are considered to be free of residual stones. |
| Operation time | 24 hours | The duration of the operation from start to finish. |
Countries
China
Contacts
Primary ContactLi Fang
Outcome results
None listed