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A Prospective Randomized Controlled Study on Efficacy and Safety of Tubeless Flexible Ureteroscopy for Renal Calculi of 1–3 cm

A Prospective Randomized Controlled Study on Efficacy and Safety of Tubeless Flexible Ureteroscopy for Renal Calculi of 1–3 cm

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128820
Enrollment
Unknown
Registered
2026-07-27
Start date
2026-07-28
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal calculi typically present with sudden and severe colic pain in the waist and abdomen, which may radiate to the lower abdomen and perineum, accompanied by gross or microscopic hematuria. Some patients experience frequent urination, urgent urination, nausea, vomiting, and abdominal distension.Urinary tract obstruction caused by calculi can lead to hydronephrosis. When complicated with infectio

Interventions

Overnight ureteral catheter group:Indwelling overnight ureteral catheter
Routine double-J stent indwelling group:Routine indwelling of ureteral stent

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 years or older; 2.Single or multiple renal calculi without significant hydronephrosis (renal pelvic dilation < 2 cm); 3.The maximum diameter of a single calculus on CT scan is 1–3 cm, and the total volume does not exceed 500 mm³. 4.Patients with controlled preoperative urinary tract infection. 5.Able to complete the study in accordance with the requirements of the trial protocol, and has been informed of the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Unable to provide informed consent; 2.Congenital or structural abnormalities of the kidney: horseshoe kidney, medullary sponge kidney, polycystic kidney, ectopic kidney, etc. 3.History of severe cardiovascular, cerebrovascular or pulmonary diseases, such as NYHA class ?-? cardiac failure, acute myocardial infarction within the past 3 months, unstable angina pectoris (CCS class ?-?), or uncontrolled severe arrhythmias; acute stroke, cerebral hemorrhage / subarachnoid hemorrhage with neurological deficits within the past 6 months; severe or very severe COPD (GOLD class 3-4), status asthmaticus, interstitial lung disease with respiratory failure, or chronic respiratory failure requiring long-term oxygen therapy. 4.Patients with uncontrolled urinary tract infection. 5.Renal calculi with definite metabolic causes: renal tubular acidosis, primary hyperoxaluria, primary hyperparathyroidism, etc. 6.History of open surgery on the affected kidney. 7.Patients with intraoperative bleeding, incomplete stone clearance, or other such conditions.

Design outcomes

Primary

MeasureTime frame
Stone Free Rate at 3 Months Postoperatively;

Secondary

MeasureTime frame
Stone composition;Hospitalization expenses;Stone migration;Hyperlipidemia;Whether a stent was preplaced;Failure of primary-stage surgery;Ureteral avulsion;Ureteral mucosal injury;Lithotripsy time;Stone CT attenuation value;age;Use of a stone basket;Sepsis;Operative time;Fever;Stone location;Ureteral stricture;Immediate postoperative stone free rate;Metabolic syndrome;Total stone diameter;Hypertension;Stent-related irritative symptoms;QOL score;Stent fracture;VAS score;Diabetes;hematuria;Ureteral perforation;IPSS score;Infection;Nausea and vomiting;Renal function impairment;Hospital stay days;Renal colic;Emergency catheterization;Preoperative urine culture;OAB score;Steinstrasse;Stent displacement;Number of stones;Intraoperative bleeding;BMI;

Countries

China

Contacts

Public ContactBin Chen

The First Affiliated Hospital of Xiamen University

chenbin5557@163.com+86 13600915557

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026