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Not yet recruiting NCT07615452

Evaluation of Renal Injury After RIRS Using Shear-Wave Elastography

No phase Interventional Kidney Stone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspiration-assisted ureteral access sheath, Standard ureteral access sheath.
Who it may be relevant to
Registry conditions: Kidney Stone. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Assessment of Renal Parenchymal Damage Following Retrograde Intrarenal Surgery Using Shear-Wave Elastography

Overview

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

  • Device Aspiration-assisted ureteral access sheath
    Patients undergoing retrograde intrarenal surgery using an aspiration-assisted ureteral access sheath
  • Device Standard ureteral access sheath
    Standard ureteral access sheath used during retrograde intrarenal surgery.

Primary outcome measures

  • Renal Cortical Shear-Wave Elastography Values (kPa) [Time frame: Elastography assessments will be performed preoperatively, on postoperative day 1, and on postoperative day 7 to evaluate perioperative renal parenchymal changes.]
Secondary outcome measures (7)
  • Postoperative Complications [Time frame: From surgery to postoperative day 30]
  • Serum Creatinine Level [Time frame: Preoperative baseline, postoperative day 1, and postoperative day 7]
  • Postoperative Fever and Sepsis [Time frame: From surgery to postoperative day 30]
  • Stone-Free Rate [Time frame: Postoperative month 1]
  • Renal Resistive Index [Time frame: Preoperative baseline, postoperative day 1 and postoperative day 7]
  • Mayo Adhesive Probability Score [Time frame: Preoperative period]
  • Postoperative Pain Scores [Time frame: preoperative, postoperative 6th hour, and postoperative 24th hour.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07615452 · canakci 003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗