Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-aspirating ureteral access sheath: A conventional ureteral access sheath that allows passive outflow of irrigation fluid during RIRS.

Aspirating ureteral access sheath: A ureteral access sheath with an active suction system that facilitates removal of irrigation fluid and stone fragments during RIRS.

Study summary

This prospective, randomized, comparative study aims to evaluate the impact of aspirating and non-aspirating ureteral access sheaths on success rates and complications in patients undergoing retrograde intrarenal surgery (RIRS) for kidney stones. A total of 70 patients with renal stones smaller than 2 cm will be enrolled and randomly assigned to two groups. One group will undergo RIRS using a non-aspirating ureteral access sheath, while the other group will be treated using an aspirating ureteral access sheath.

The primary outcome of the study is the stone-free rate, which will be assessed at postoperative follow-up. Secondary outcomes include operative time, fluoroscopy time, length of hospital stay, postoperative complications according to the Clavien-Dindo classification, infection-related parameters, and the need for ureteral stenting.

The study aims to determine whether the use of an aspirating access sheath improves surgical outcomes by reducing intrarenal pressure, enhancing visualization, and decreasing complication rates. The findings are expected to contribute to optimizing device selection and improving clinical outcomes in endoscopic kidney stone surgery.

Eligibility

Primary outcome measure(s)

• Stone-free status — At 3 weeks postoperatively
  Stone-free status is defined as the absence of residual stones on low-dose non-contrast computed tomography or plain urinary system radiography at 3 weeks postoperatively.

Trial sites (1)

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