Kidney Stone
Conditions
Keywords
Retrograde intrarenal surgery, Shear-wave elastography, Kidney injury, kidney stone
Brief summary
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.
Interventions
DEVICEAspiration-assisted ureteral access sheath
Patients undergoing retrograde intrarenal surgery using an aspiration-assisted ureteral access sheath
Standard ureteral access sheath used during retrograde intrarenal surgery.
Sponsors
Cengiz Canakci, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Patients undergoing RIRS for renal stones * Stone size between \< 20 mm * Negative urine culture
Exclusion criteria
* Active urinary tract infection * Congenital renal anomalies * Solitary kidney * Chronic kidney disease * Previous PCNL or open surgery * Ureteral stricture disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal Cortical Shear-Wave Elastography Values (kPa) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complications | From surgery to postoperative day 30 | Perioperative and postoperative complications assessed according to the Clavien-Dindo classification system. |
| Serum Creatinine Level | Preoperative baseline, postoperative day 1, and postoperative day 7 | Serum creatinine levels measured to evaluate renal function changes following retrograde intrarenal surgery. |
| Postoperative Fever and Sepsis | From surgery to postoperative day 30 | Occurrence of postoperative fever (\>38°C) and/or sepsis following surgery. |
| Stone-Free Rate | Postoperative month 1 | Stone-free status assessed by postoperative imaging. |
| Renal Resistive Index | 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. |
| Mayo Adhesive Probability Score | 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. |
| Postoperative Pain Scores | 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. |
Contacts
CONTACTCengiz Çanakcı
Outcome results
None listed