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

Ain Shams University90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Traditional ureteral access sheath retrograde intrarenal surgeryPROCEDURE

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.

Suction ureteral access sheath retrograde intrarenal surgeryPROCEDURE

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.

Sheathless retrograde intrarenal surgeryPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Stone-free rate assessed by non-contrast computed tomography of the urinary tract

Stone-free status is evaluated using non-contrast computed tomography of the urinary tract performed after surgery. Residual stone fragments are classified into four grades: Grade A, no stones detected (absolute stone-free); Grade B, residual fragments less than or equal to 2 millimeters (relative stone-free); Grade C, residual fragments 2.1 to 4 millimeters (relative stone-free); and Grade D, residual fragments greater than 4 millimeters (significant residual stones). The primary endpoint is the proportion of patients achieving stone-free status, defined as Grade A (absolute stone-free) and, in a secondary analysis, Grades A to C combined (clinically insignificant residual fragments).

Time frame: One month after surgery (non-contrast computed tomography of the urinary tract performed approximately 30 days postoperatively)

Secondary Outcomes

Operative time for retrograde intrarenal surgery

Operative time is measured in minutes from the insertion of the endoscopic instruments at the beginning of retrograde intrarenal surgery until completion of the procedure, including placement of the double-J ureteral stent. The metric is the mean operative time and distribution of operative time for each study arm.

Time frame: During the surgical procedure on the day of surgery