Comparing Vacuum-Assisted and Conventional Ureteral Access Sheaths in Kidney Stone Surgery to Evaluate Safety and Effectiveness

What this Trial Is About

Researchers are evaluating two types of ureteral access sheaths used during retrograde intrarenal surgery RIRS to treat upper urinary tract stones. The study compares the safety and effectiveness of vacuum-assisted access sheaths with conventional non-vacuum-assisted sheaths. This randomized controlled prospective multicenter trial aims to measure stone-free rates and complications following surgery, addressing the need for clearer evidence on the benefits of vacuum-assisted sheaths. The trial involves two groups one receiving RIRS with a conventional ureteral access sheath and the other with a vacuum-assisted sheath that includes flexible tips and aspiration to remove stone fragments during surgery. The vacuum-assisted sheath is designed to improve visualization by continuously removing fragments and reducing bleeding, potentially leading to shorter operation times and fewer postoperative infections. Both groups undergo standard RIRS procedures with these different sheath types. Participants will be monitored with a non-contrast abdominal CT scan one month after surgery to assess stone-free status. Complications will be tracked during and after the operation, including hospitalization and follow-up within the first month. The study starts with patient selection and randomization, followed by intervention and postoperative evaluations to assess outcomes such as stone clearance and complication rates.

Comparison of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery