Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones - A Randomized Controlled Multi-center Clinical Trials
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- Success rate of ureteral access sheath insertion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
9.0Fr disposable electronic flexible ureteroscope combine with 12Fr distally deflectable ureteral access sheath.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
7.5Fr fURS and 10Fr UAS
7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath.
Intervention: flexible ureteroscope urolithiasis (Procedure)
9.0Fr fURS and 12Fr UAS
9.0Fr disposable electronic flexible ureteroscope combine with 12Fr distally deflectable ureteral access sheath.
Intervention: flexible ureteroscope urolithiasis (Procedure)
Outcomes
Primary Outcomes
Success rate of ureteral access sheath insertion
Time Frame: From enrollment to completion of surgery
Proportion of successful ureteral implantation, success rate = number of successful cases/total number of cases
Secondary Outcomes
- The condition of ureter injury(24 hours)
- Stone clearance rate(up to 8 weeks.)
- Operation time(24 hours)
- The incidence of surgical complications(7 days)