Health TrialsbyHealthPanel

Evaluation of Renal Injury After RIRS Using Shear-Wave Elastography

ConditionKidney Stone
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCengiz Canakci, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Patients undergoing RIRS for renal stones

Stone size between < 20 mm

Negative urine culture

Disqualifiers

Active urinary tract infection

Congenital renal anomalies

Solitary kidney

Chronic kidney disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aspiration-assisted ureteral access sheath

    Device

    Patients undergoing retrograde intrarenal surgery using an aspiration-assisted ureteral access sheath

  • Standard ureteral access sheath

    Device

    Standard ureteral access sheath used during retrograde intrarenal surgery.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Aspiration-assisted ureteral access sheathExperimental treatment 1 intervention
Group B: Standard ureteral access sheathActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Renal Cortical Shear-Wave Elastography Values (kPa)

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
Elastography assessments will be performed preoperatively, on postoperative day 1, and on postoperative day 7 to evaluate perioperative renal parenchymal changes.

Secondary outcomes

1

Postoperative Complications

Perioperative and postoperative complications assessed according to the Clavien-Dindo classification system.

Time frame
From surgery to postoperative day 30
2

Serum Creatinine Level

Serum creatinine levels measured to evaluate renal function changes following retrograde intrarenal surgery.

Time frame
Preoperative baseline, postoperative day 1, and postoperative day 7
3

Postoperative Fever and Sepsis

Occurrence of postoperative fever (\>38°C) and/or sepsis following surgery.

Time frame
From surgery to postoperative day 30
4

Stone-Free Rate

Stone-free status assessed by postoperative imaging.

Time frame
Postoperative month 1

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cengiz Canakci, MD

Lead sponsor

Lütfi Kırdar City Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: