NCT07289230

Sheathless, Traditional, and Suction Access Sheath RIRS for Renal Stones ≤2 cm

A Comparative Study Between Sheathless RIRS, Traditional Access Sheath RIRS, and Suction Access Sheath RIRS in the Management of Renal Stones ≤ 2 cm: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This completed randomized clinical study was designed to compare three different techniques of retrograde intrarenal surgery (retrograde intrarenal surgery) for the treatment of kidney stones that are 2 centimeters or smaller. Retrograde intrarenal surgery is a minimally invasive procedure in which a flexible scope is passed through the urinary tract to reach the kidney and fragment the stone. The clinical study included three groups of patients. The first group underwent retrograde intrarenal surgery using a traditional ureteral access sheath, which is a hollow tube placed in the ureter to facilitate the passage of instruments and help control pressure inside the kidney. The second group underwent retrograde intrarenal surgery using a suction ureteral access sheath, which combines the function of a traditional sheath with gentle suction to help remove stone fragments and reduce internal pressure. The third group underwent sheathless retrograde intrarenal surgery, in which the flexible surgical scope is inserted directly without the use of any ureteral access sheath. The purpose of this clinical study was to determine whether these three approaches differ in terms of stone clearance, operative time, intraoperative complications such as bleeding or fluid leakage, and early postoperative complications such as fever or infection. All participants were adults with a single kidney stone between 1 and 2 centimeters, normal kidney function, and no active infection or anatomical abnormalities. All procedures were performed at Ain Shams University Hospitals using the same surgical equipment and technique to ensure comparability between groups.

Conditions

• Kidney Calculi
• Renal Calculi
• Urolithiasis
• Nephrolithiasis

Interventions

Type	Name	Description
PROCEDURE	Traditional ureteral access sheath retrograde intrarenal surgery	This intervention involves performing retrograde intrarenal surgery using a traditional ureteral access sheath to facilitate entry of the flexible ureteroscope and maintain controlled intrarenal pressure. The procedure includes endoscopic fragmentation of renal calculi using a holmium:yttrium-aluminum-garnet laser device and placement of a double-J ureteral stent at the end of surgery.
PROCEDURE	Suction ureteral access sheath retrograde intrarenal surgery	This intervention uses a suction ureteral access sheath that provides continuous negative pressure during retrograde intrarenal surgery. The system assists in evacuation of stone debris and helps control intrarenal pressure while the flexible ureteroscope and holmium:yttrium-aluminum-garnet laser device are used for stone fragmentation. A double-J ureteral stent is placed after the procedure.
PROCEDURE	Sheathless retrograde intrarenal surgery	This intervention involves performing retrograde intrarenal surgery without the use of any ureteral access sheath. The flexible ureteroscope is introduced directly over a guidewire to access the renal collecting system for laser fragmentation of the stone using a holmium:yttrium-aluminum-garnet laser device. A double-J ureteral stent is inserted following completion of the procedure.

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: Egypt