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Ureteral Access Strategies in Retrograde Intrarenal Surgery
Sponsor: Ondokuz Mayıs University
Summary
Retrograde intrarenal surgery (RIRS) is a standard minimally invasive treatment for kidney stones up to 20 mm. During the procedure, irrigation fluid raises the pressure inside the kidney and laser energy raises the fluid temperature. High intrarenal pressure has been linked to postoperative pain, fever and infection. Ureteral access sheaths are used to improve fluid outflow, and newer flexible and navigable suction access sheaths (FANS) add active aspiration to keep pressure low and remove stone fragments. This randomized controlled trial compares three ureteral access strategies in adults undergoing RIRS: a flexible and navigable suction access sheath, a conventional ureteral access sheath, and no access sheath. The main question is whether the access strategy affects pain 6 hours after surgery. The study also compares intrarenal pressure and temperature during surgery, the amount of irrigation fluid used and retained, stone-free status on computed tomography (CT), and complications.
Official title: Effect of Flexible and Navigable Suction Ureteral Access Sheath (FANS), Conventional Ureteral Access Sheath and Sheathless Approach on Intraoperative Parameters and Postoperative Clinical Outcomes in Retrograde Intrarenal Surgery: A Prospective Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2026-11-01
Completion Date
2027-07-01
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Flexible and navigable suction ureteral access sheath
A \[10/12\] Fr flexible and navigable suction ureteral access sheath (\[brand/model\]) with a flexible distal tip that follows the ureteroscope into the renal calyces. The side port is connected to a suction unit set at \[x\] mmHg, providing continuous aspiration of irrigation fluid and stone fragments during lithotripsy.
Conventional ureteral access sheath
A \[10/12\] Fr standard (non-suction) ureteral access sheath (\[brand/model\]) placed with its tip at the level of the ureteropelvic junction. Irrigation fluid drains passively through the sheath around the ureteroscope.
Sheathless flexible ureteroscopy
Flexible ureteroscopy performed without a ureteral access sheath. The flexible ureteroscope is advanced over a guidewire after diagnostic semirigid ureteroscopy and passive ureteral dilatation.
Retrograde intrarenal surgery with laser lithotripsy
Standardized retrograde intrarenal surgery under general anesthesia using a flexible ureteroscope with integrated intrarenal pressure sensing and Holmium:YAG laser lithotripsy with standardized settings. Intrarenal pressure and fluid temperature are recorded continuously, irrigation and outflow volumes are measured, and a double-J stent is placed at the end of the procedure in all patients.
Locations (1)
Ondokuz Mayis University, Samsun
Samsun, Turkey (Türkiye)