Trial Outcomes & Findings for Effects of Flexible Ureteroscopy on Renal Blood Flow (NCT NCT03023488)

Results Overview

Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV. PSV is the maximum velocity in the renal and arcuate arteries in the systolic phase of each heart pulse.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation

Results posted on

2018-07-06

Participant Flow

Participant milestones

Participant milestones
Measure	Flexible Ureteroscopy Arm Doppler Ultrasound examination was performed in both the pre-operative and post-operative periods on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
Overall Study STARTED	46
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Flexible Ureteroscopy on Renal Blood Flow

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flexible Ureteroscopy Arm n=46 Participants findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
Age, Continuous	41.24 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Body Mass Index (BMI) units: kg/m2	26.49 kg/m2 STANDARD_DEVIATION 4.97 • n=5 Participants
Stone volume	1685 mm3 n=5 Participants

PRIMARY outcome

Timeframe: The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation

Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV. PSV is the maximum velocity in the renal and arcuate arteries in the systolic phase of each heart pulse.

Outcome measures

Outcome measures
Measure	Flexible Ureteroscopy Arm n=46 Participants pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
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. pre-operative PSV	30.65 cm/s Interval 18.0 to 82.2
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. post-operative PSV	31.85 cm/s Interval 16.5 to 84.1

PRIMARY outcome

Timeframe: The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation

Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV. EDV is the velocity in the renal and arcuate arteries at the end of the diastolic phase of each heart pulse.

Outcome measures

Outcome measures
Measure	Flexible Ureteroscopy Arm n=46 Participants pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
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. pre-operative EDV	12.3 cm/s Interval 2.2 to 41.3
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. post-operative EDV	12 cm/s Interval 4.4 to 34.1

PRIMARY outcome

Timeframe: The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation

Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV. Resistive index is calculated as the difference between PSV and EDV, divided by PSV \[(PSV - EDV) / (PSV)\]. An increased resistive index can be considered as a marker of intrarenal arterial stiffness and is associated with worsening of renal function and tubulointersitial damage.

Outcome measures

Outcome measures
Measure	Flexible Ureteroscopy Arm n=46 Participants pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
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. pre-operative RI	0.59 unitless Interval 0.45 to 0.85
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. post-operative RI	0.59 unitless Interval 0.41 to 0.89

PRIMARY outcome

Timeframe: The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation

Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV. Pulsatility index is calculated as the difference between PSV and EDV, divided by the mean velocity \[(PSV - EDV) / ((PSV + EDV) / 2)\]. Pulsatility index is used to discriminate between renal and pre-renal causes of acute kidney injury which can alter the therapeutic options in the clinical setting.

Outcome measures

Outcome measures
Measure	Flexible Ureteroscopy Arm n=46 Participants pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
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. pre-operative PI	0.89 unitless Interval 0.59 to 1.71
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. post-operative PI	0.89 unitless Interval 0.54 to 1.98

SECONDARY outcome

Timeframe: 1 hour after the operation

The size of access sheaths will be given in French measurement. E.g. 10/12 Fr

Outcome measures

Outcome measures
Measure	Flexible Ureteroscopy Arm n=46 Participants pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
Technical Details - Size of Ureteral Access Sheath 9.5/11.5 Fr	28 participants
Technical Details - Size of Ureteral Access Sheath 10/12 Fr	9 participants
Technical Details - Size of Ureteral Access Sheath 12/14 Fr	9 participants

SECONDARY outcome

Timeframe: 1 hour after the operation

Each ureteroscope has unique characteristics. So, every ureteroscope that will be used, will be recorded with its name. E.g. Storz Flex-X2, Olympus V1, Wolf Cobra

Outcome measures

Outcome measures
Measure	Flexible Ureteroscopy Arm n=46 Participants pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
Technical Details - Name of Flexible Ureteroscope Storz Flex X2	41 participants
Technical Details - Name of Flexible Ureteroscope Storz Flex XC	5 participants

SECONDARY outcome

Timeframe: 10 minutes after the operation

the data about the duration of the operation that will be performed for each patient and the data will be recorded in minutes.

Outcome measures

Outcome measures
Measure	Flexible Ureteroscopy Arm n=46 Participants pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
Duration of the Flexible Ureteroscopy Operation	62.2 min Standard Deviation 22.4

SECONDARY outcome

Timeframe: 1 hour after the operation

The pressure that is applied to the irrigation solution which is circulated through the ureteroscope that is used to expand the renal cavities during a flexible ureteroscopy operation. the data will be collected in cmH2O. This pressure value is a constant value and it doesn't change throughout the length of the procedure.

Outcome measures

Outcome measures
Measure	Flexible Ureteroscopy Arm n=46 Participants pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
Operative Characteristics - Irrigation Pressure	50 cmH2O Interval 40.0 to 60.0

SECONDARY outcome

Timeframe: 1 hour after the operation

The number of patients that has experienced any kind of intraoperative complications during the flexible ureteroscopy operation.

Outcome measures

Outcome measures
Measure	Flexible Ureteroscopy Arm n=46 Participants pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
Operative Characteristics - Intraoperative Complications	5 participants

SECONDARY outcome

Timeframe: The data will be recorded within 1 month after each procedure.

The number of patients that had a complication in the first 1 month after the operation according to the Clavien Dindo Grading system (0-5). Clavien Dindo Grading ranges from 0 (mildest) to 5 (most severe). 0. No complications 1. Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside 2. Complications requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included 3. Complications requiring surgical, endoscopic or radiological intervention 4. Life-threatening complications (including CNS complications) requiring IC/ICU management 5. Death

Outcome measures

Outcome measures
Measure	Flexible Ureteroscopy Arm n=46 Participants pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
Post-Operative Characteristics - Complications Grade 0	41 Participants
Post-Operative Characteristics - Complications Grade 1	3 Participants
Post-Operative Characteristics - Complications Grade 2	1 Participants
Post-Operative Characteristics - Complications Grade 3	0 Participants
Post-Operative Characteristics - Complications Grade 4	1 Participants
Post-Operative Characteristics - Complications Grade 5	0 Participants

Adverse Events

Flexible Ureteroscopy Arm

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flexible Ureteroscopy Arm n=46 participants at risk findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
Renal and urinary disorders Sepsis	4.3% 2/46 • Number of events 2

Other adverse events

Other adverse events
Measure	Flexible Ureteroscopy Arm n=46 participants at risk findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision. Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated. laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans
Renal and urinary disorders Urinary tract infection	6.5% 3/46

Additional Information

Dr. Tarik Emre Sener

Marmara University, School of Medicine, Department of Urology

Phone: +905337620712

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place