Aspiration-assisted ureteral access sheath
DevicePatients undergoing retrograde intrarenal surgery using an aspiration-assisted ureteral access sheath
NCT Number: NCT07615452
This study aims to evaluate changes in renal parenchyma following retrograde intrarenal surgery (RIRS) using shear-wave elastography. Renal elastography measurements will be performed in patients undergoing RIRS for kidney stones on the preoperative day, on the first postoperative day, and on the seventh postoperative day. Postoperative pain scores, perioperative outcomes, stone-free status and complications will also be assessed.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients undergoing retrograde intrarenal surgery using an aspiration-assisted ureteral access sheath
Standard ureteral access sheath used during retrograde intrarenal surgery.
Time frame: Elastography assessments will be performed preoperatively, on postoperative day 1, and on postoperative day 7 to evaluate perioperative renal parenchymal changes.
Renal cortical stiffness will be quantitatively evaluated using ultrasound-based shear-wave elastography. Measurements will be obtained from multiple regions of the renal cortex, and the mean value of these measurements will be recorded in kilopascals (kPa). All examinations will be performed using the same ultrasound device and standardized protocol by a single experienced radiologist blinded to the study groups.
Time frame: From surgery to postoperative day 30
Perioperative and postoperative complications assessed according to the Clavien-Dindo classification system.
Time frame: Preoperative baseline, postoperative day 1, and postoperative day 7
Serum creatinine levels measured to evaluate renal function changes following retrograde intrarenal surgery.
Time frame: From surgery to postoperative day 30
Occurrence of postoperative fever (>38°C) and/or sepsis following surgery.
Time frame: Postoperative month 1
Stone-free status assessed by postoperative imaging.
Time frame: Preoperative baseline, postoperative day 1 and postoperative day 7
Renal resistive index values measured using Doppler ultrasonography to evaluate renal vascular resistance following retrograde intrarenal surgery.
Time frame: Preoperative period
Perinephric fat adhesion severity assessed using the Mayo Adhesive Probability (MAP) Score based on preoperative computed tomography findings. The MAP Score ranges from 0 to 5, with higher scores indicating a greater likelihood of adherent perinephric fat and increased surgical complexity.
Time frame: preoperative, postoperative 6th hour, and postoperative 24th hour.
. Postoperative pain intensity was assessed using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the most severe pain imaginable. Higher scores indicate greater pain intensity.
Contact information is provided by the study sponsor or research team.
Cengiz Canakci, MD
Other
Assessment of Renal Parenchymal Damage Following Retrograde Intrarenal Surgery Using Shear-Wave Elastography
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