The goal of this clinical trial is to determine the efficacy and safety of a novel intelligent pressure and temperature-controlled ureteroscope system for treating renal and upper ureteral stones with concurrent infection. It will also assess its ability to reduce postoperative complications and improve stone clearance rates. The main questions it aims to answer are: Does the intelligent system lower the complication rate and enhance stone clearance compared to standard ureteroscopy? What safety issues or medical problems do participants experience when using the intelligent system? Researchers will compare the intelligent pressure and temperature-controlled ureteroscope system to a standard ureteroscope to evaluate its effectiveness in treating renal and upper ureteral stones. Participants will: Undergo surgery using either the intelligent system or a standard ureteroscope Be monitored for postoperative complications, stone clearance, and other relevant outcomes Participate in follow-up visits to assess recovery and treatment efficacy
This study protocol describes a multi-center, prospective, randomized controlled trial with a non-inferiority design, aiming to assess the efficacy and safety of an intelligent pressure and temperature-controlled ureteroscope system for treating renal and upper ureteral stones with concurrent infection. A total of 288 patients will be randomized into two groups (1:1 ratio), with the intervention group receiving the intelligent system and the control group undergoing standard ureteroscopy. The primary endpoints are the complication rate and stone clearance rate at 1 month postoperatively, while secondary endpoints include short-term stone clearance, intraoperative and postoperative complications, infection markers, surgical time, and intraoperative pressure and temperature monitoring. The study will adhere to rigorous ethical standards and statistical analysis plans to provide robust evidence for the clinical application of this novel device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
288
RIRS procedure for upper ureteral or renal stone lithotripsy with Intelligent Pressure and Temperature-Controlled Ureteroscope System
RIRS procedure for upper ureteral or renal stone lithotripsy with conventional ureteroscope
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Postoperative Complication Rate
This composite outcome measure includes the incidence of the following complications: 1. Fever: Defined as body temperature ≥38℃. 2. Urinary Sepsis: An increase in the Sequential Organ Failure Assessment (SOFA) score by ≥2 points postoperatively. 3. Septic Shock: Requires vasopressors to maintain mean arterial pressure ≥65 mmHg after adequate fluid resuscitation, with blood lactate concentration \>2 mmol/L 4. Pain: Assessed using the Numeric Rating Scale (NRS) within 48 hours postoperatively, recording the need for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) or other analgesic treatment. 5. Renal subcapsular or perirenal hematomaL: Diagnosed by Computed Tomography (CT) or other imaging within 30 days postoperatively. The composite postoperative complication rate will be calculated as the number of patients with at least one complication divided by the total number of patients in the study, multiplied by 100 to obtain a percentage.
Time frame: Assessed at 48 hours and 1 month postoperatively.
Stone Free Rate
This is defined as the proportion of patients with no residual stones or residual stones ≤2mm in diameter and asymptomatic, as confirmed by renal CT at 1 month postoperatively.
Time frame: Assessed at 1 month postoperatively.
Stone Clearance Rate at 48 hours postoperatively
The proportion of patients with no residual stones or residual stones ≤2mm in diameter and asymptomatic, as confirmed by renal CT at 48 hours postoperatively.
Time frame: Assessed at 48 hours postoperatively.
Intraoperative Complications Rate
The incidence of intraoperative complications, including ureteral or renal pelvis perforation, ureteral mucosal stripping, ureteral rupture, the need for conversion to other treatments, and failure of ureteral access sheath placement.
Time frame: Assessed at 2 hours after the surgical procedure.
Concentration of postoperative infection markers
Changes in the concentration of postoperative infection markers Procalcitonin (PCT) and C-reactive protein (CRP), hemoglobin (Hb), serum creatinine (Scr), and blood urea nitrogen (BUN).
Time frame: Assessed at 48 hours postoperatively during hospitalization.
Intraoperative Pressure
The intraoperative pressure values recorded during the procedure measured by the intelligent pressure and temperature control ureteral soft scope system.
Time frame: Assessed 2 hours after the surgical procedure.
Intraoperative Temperature
The intraoperative temperature values recorded during the procedure.
Time frame: Assessed at 2 hours after the surgical procedure.
Postoperative Hospital Stay
The length of hospital stay following the surgical procedure.
Time frame: Assessed at 24 hours after patients leaving the hospital
Surgical and Lithotripsy Time
The duration of the surgical procedure and the time required for lithotripsy.
Time frame: Assessed at 24 hours postoperatively.
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