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

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.

Inclusion Criteria:

• Adult patients aged 18 years or older.
• Symptomatic unilateral single renal stone with a maximal diameter from 1 centimeter to 2 centimeters.
• Normal kidney function based on routine laboratory tests.
• Patients willing and able to provide written informed consent to participate in the clinical study.

Exclusion Criteria:

• Patients with active urinary tract infection (UTI) until appropriate treatment is completed and infection is cleared.
• Patients with anatomical abnormalities of the urinary tract (for example, congenital or acquired structural abnormalities).
• Pregnant patients.
• Patients who are medically unfit for general anesthesia.
• Patients with multiple renal stones in the same kidney or bilateral renal stones.