N/A
N=46
Effects of Flexible Ureteroscopy on Renal Blood Flow
Circulatory; Change
Bottom Line
View on ClinicalTrials.gov: NCT03023488 ↗Enrolled (actual)
46
Serious AEs
4.4%
Results posted
May 2017
Primary outcome: Primary: Peak Systolic Velocities (PSV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters. — 30.65; 31.85 cm/s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- flexible ureteroscopy (Procedure); Doppler Ultrasound examination (Device); laser lithotripsy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Marmara University
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Systolic Velocities (PSV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters. |
30.65; 31.85 | — |
| PRIMARY End Diastolic Velocities (EDV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters. |
12.3; 12 | — |
| PRIMARY Resistive Index (RI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters. |
0.59; 0.59 | — |
| PRIMARY Pulsatility Index (PI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters. |
0.89; 0.89 | — |
| SECONDARY Technical Details - Size of Ureteral Access Sheath |
28; 9; 9 | — |
| SECONDARY Technical Details - Name of Flexible Ureteroscope |
41; 5 | — |
| SECONDARY Duration of the Flexible Ureteroscopy Operation |
62.2 | — |
| SECONDARY Operative Characteristics - Irrigation Pressure |
50 | — |
| SECONDARY Operative Characteristics - Intraoperative Complications |
5 | — |
| SECONDARY Post-Operative Characteristics - Complications |
41; 3; 1; 0; 1; 0 | — |
Summary
Aim of this study is to investigate the effects of increased intrarenal pressure during flexible ureteroscopy on renal blood flow.
Patients undergoing flexible ureteroscopy (F-URS) and laser lithotripsy for kidney stones according to European Association of Urology (EAU) guidelines on Urolithiasis will be included in the study after having signed an informed consent form. The pre- and post-operative evaluation and management will be performed according to EAU Guidelines on Urolithiasis. Additionally, as a non-invasive test, bilateral renal power Doppler US will be performed to patients pre- and post-operatively. The pre-operative Doppler US will be performed 2 days prior to surgery and the post-operative Doppler US will be performed in the first 24 hours following surgery. The changes on blood flow in renal artery and arcuate artery will be recorded.
Eligibility Criteria
Inclusion Criteria
- Patients between ages 18-65
- Patients undergoing flexible ureteroscopy + laser lithotripsy according to EAU Guidelines on Urolithiasis
Exclusion Criteria
- Pregnant patients
- Patients with already-diagnosed urological malignancies
- Patients ineligible for flexible ureteroscopy due to concomitant co-morbidities
Data sourced from ClinicalTrials.gov (NCT03023488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.