Use of ureteral access sheaths in ureteroscopy.
Adam G Kaplan, Michael E Lipkin, Charles D Scales...
https://pubmed.ncbi.nlm.nih.gov/26597613/Actively Recruiting
Led by Helwan University · Updated on 2026-02-03
100
Participants Needed
1
Research Sites
7 weeks
Total Duration
This research aims to compare the safety and effectiveness of two types of ureteral access sheaths used during retrograde intrarenal surgery RIRS for managing staghorn renal stones. Staghorn renal calculi are complex kidney stones that fill the renal pelvis and branch into the kidneys calyces. Although percutaneous nephrolithotomy is the standard treatment, RIRS is a less invasive option increasingly used, especially for patients unsuitable for the traditional approach. The study evaluates whether a new bendable tip-suction sheath improves surgical outcomes compared to a conventional sheath. Participants will undergo retrograde intrarenal surgery using either a bendable tip-suction ureteral access sheath connected to a suction system or a conventional ureteral access sheath. The bendable sheath is designed to reach targeted kidney areas more effectively, maintain a clear view by continuous suction, and remove stone fragments during laser lithotripsy. The study randomly assigns patients to one of these two groups to assess differences in safety and efficiency. During the study, patient safety will be monitored from surgery through one month afterward to evaluate the surgical techniques safety. The effectiveness of the surgery will be measured one month post-operation. Participants will be assessed with renal function tests and followed for any complications, with data collected on surgical outcomes and recovery. The total participation duration includes the surgery and follow-up period of at least one month.
CONDITIONS
Using Retrograde Intrarenal Surgery for Managing Staghorn Renal Stones.
A
Ahmed H Elsergany, MSc.
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Helwan University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - During surgery to one month after surgery
Participants undergo retrograde intrarenal surgery using either a bendable tip-suction ureteral access sheath or a conventional ureteral access sheath to manage renal staghorn stones.
1 surgical procedure and follow-up visits up to 1 month
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/37915008/Helwan University
Lead Sponsor