Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNingbo No. 1 Hospital
About this trial
Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
1.Patients with a history of ureteral stenosis or who have undergone open or laparoscopic ureteral or renal lithotomy.
Trial design
Design model
Factorial
Treatments tested in this trial
flexible ureteroscope urolithiasis
Procedure/SurgeryUsing flexible ureteroscope combine with urethral access sheath to treatment urolithiasis
Treatment groups
206 Participants
are divided into 2 treatment groupsGroup A: 7.5Fr fURS and 10Fr UASExperimental treatment 1 intervention
Group B: 9.0Fr fURS and 12Fr UASActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Success rate of ureteral access sheath insertion
Proportion of successful ureteral implantation, success rate = number of successful cases/total number of cases
Time frame
From enrollment to completion of surgerySecondary outcomes
1
The condition of ureter injury
The ureter was observed at exit of the ureteroscope and graded according to Traxer's proposed grading system.
Time frame
24 hours2
Stone clearance rate
Residual stones less than 4 mm are considered to be free of residual stones.
Time frame
up to 8 weeks.3
Operation time
The duration of the operation from start to finish.
Time frame
24 hours4
The incidence of surgical complications
The occurrence of postoperative fever, urogenic sepsis and septic shock
Time frame
7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ningbo No. 1 Hospital
Lead sponsor
The First People's Hospital of Fuyang District, Hangzhou City
Collaborator
The Central Hospital of Lishui City
Collaborator
Source ClinicalTrials.gov