About this trial
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 criteria
Qualifiers
Patients aged between 18 and 75 years
Patients diagnosed with kidney stones smaller than 2 cm
Patients scheduled for retrograde intrarenal surgery (RIRS)
Patients who provide written informed consent
Disqualifiers
Patients with active urinary tract infection
Patients with coagulopathy
Pregnant patients
Patients unable to tolerate the lithotomy position
Trial design
Treatments tested in this trial
- Non-aspirating ureteral access sheath
- Aspirating ureteral access sheath