Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery.
Olivier Traxer, Alexandre Thomas
https://pubmed.ncbi.nlm.nih.gov/22982421/Actively Recruiting
Led by Namik Kemal University · Updated on 2026-07-06
108
Participants Needed
1
Research Sites
N/A
Total Duration
Kidney stone disease is a common health problem treated often with a minimally invasive procedure called retrograde intrarenal surgery RIRS. This trial compares two types of ureteral access sheaths used during RIRS an aspiration-enabled flexible navigable sheath and a conventional sheath. The study aims to find out if better pressure control during surgery can reduce early kidney injury, measured by sensitive blood and urine markers IL-18 and L-FABP, which detect kidney damage sooner than standard tests. Participants will undergo RIRS with either the flexible navigable aspiration sheath or the conventional sheath. The aspiration system continuously removes irrigation fluid to better control pressure inside the kidney. The study will monitor differences in kidney injury after surgery between these two groups by measuring biomarker levels before surgery, 24 hours after, and 7 days postoperatively. During the study, participants will have blood and urine samples collected at specified times to assess kidney injury. Researchers will track acute kidney injury using these biomarkers and observe intrarenal pressure controls effect on kidney function. The trial involves random assignment to either device group and single masking. Total participant involvement spans from preoperative assessment through at least one week after surgery to monitor outcomes.
CONDITIONS
COMPARISON OF FANS VS CONVENTIONAL URETERAL ACCESS SHEATH in RIRS on POSTOPERATIVE ACUTE KIDNEY INJURY
M
mehmet fatih M. şahin, associate professor
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Namik Kemal University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo retrograde intrarenal surgery (RIRS) using either the flexible navigable aspiration ureteral access sheath or the conventional sheath.
1 surgical visit
Duration - 7 days
Participants have blood and urine tests before surgery, 24 hours after, and 7 days postoperatively to measure kidney injury markers.
3 visits
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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Olivier Traxer, Alexandre Thomas
https://pubmed.ncbi.nlm.nih.gov/22982421/Gökhan Ecer, Mehmet Giray Sönmez, Selçuk Güven...
https://pubmed.ncbi.nlm.nih.gov/37133619/Namik Kemal University
Lead Sponsor