Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery

ConditionKidney Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHitit University

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

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators