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A prospective randomized controlled study on the efficacy evaluation of flexible ureteroscopy combined with suction in the treatment of patients with 2~3cm intrarenal stones using different positions

A prospective randomized controlled study on the efficacy evaluation of flexible ureteroscopy combined with suction in the treatment of patients with 2~3cm intrarenal stones using different positions

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091453
Enrollment
Unknown
Registered
2024-10-29
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

Renal calculi

Interventions

Lateral position suction sheath group:using suction sheath, lateral recumbent position
Lateral position ordinary sheath group:using non-suction sheath, lateral recumbent position
Lithotomy position suction sheath group:using suction sheath, lithotomy position
Lithotomy position ordinary sheath group.:using non-suction sheath, lithotomy position

Sponsors

The Fifth Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients with renal calculi with a single stone diameter of 2-3 cm or a stone burden of 4.18 cm³-14.13 cm³ and requiring flexible ureteroscopy for treatment. 2.Ages between 18 and 70 years old, regardless of gender. 3.Subjects without mental illness or language dysfunction, who can understand the situation of this study and voluntarily agree to participate in the study.

Exclusion criteria

Exclusion criteria: 1.Patients with severe hydronephrosis on the affected side. 2.Those with upper urinary tract malformation or stricture. 3.Patients with uncontrolled urinary tract infection before surgery (blood white blood cell count greater than 10*10^9/L, bacteria seen on urine sediment smear examination or positive urine bacterial culture. After infection control and normalization of indicators, they can continue to be enrolled). 4.Those with poorly controlled blood sugar and blood pressure (systolic blood pressure greater than 150 mmHg or less than 90 mmHg, diastolic blood pressure greater than 100 mmHg or less than 60 mmHg. Fasting blood sugar greater than 7.0 mmol/L, postprandial blood sugar greater than 11.1 mmol/L, and glycosylated hemoglobin greater than 6.5%). 5.Pregnant women with renal calculi. 6.Those who are unable to tolerate surgery as evaluated before surgery. 7.Those who, in the opinion of the researcher, have other situations not suitable for participating in the study.

Design outcomes

Primary

MeasureTime frame
Stone clearance rate;Clavien-Dindo Complication Score;

Secondary

MeasureTime frame
operation time;length of hospital stay;Basal intrapelvic pressure;Mean intrapelvic pressure;Maximum intrapelvic pressure;duration of intrapelvic pressure greater than 40 cm H2O;white blood count;Neutrophil ratio;Hemoglobin count;Platelet count;Procalcitonin;Interleukin 6;Serum potassium;Serum sodium;serum creatinine;The days of feve;

Countries

China

Contacts

Public ContactJun Bian

The Fifth Affiliated Hospital of Guangzhou Medical University

bianjun39@163.com+86 136 6005 8795

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026