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Multi-center randomized controlled trial for soton ureteroscopy combined with flexible ureteroscopy versus flexible ureteroscopy for the treatment of renal calculi

Multi-center randomized controlled trial for soton ureteroscopy combined with flexible ureteroscopy versus flexible ureteroscopy for the treatment of renal calculi

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019650
Enrollment
Unknown
Registered
2018-11-20
Start date
2019-05-01
Completion date
Unknown
Last updated
2018-11-26

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

Conditions

renal calculi

Interventions

Group 1:Soton ureteroscopy combined with flexible ureteroscopy
Group 2:Flexible ureteroscopy

Sponsors

Department of Urology, Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-65 years old; (2) Imaging confirmed positive stones, stones in the kidney, the number of stones =1, the largest diameter of 2-3cm, or the largest diameter of 1-2cm, ineffective by extracorporeal shock wave lithotripsy or unwilling to undergo extracorporeal shock wave lithotripsy; (3) Agree to participate in this clinical study, complete postoperative follow-up and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Combined with ureteral stones, bladder stones, etc., or the maximum diameter of the inferior calculi stones > 1.0 cm; (2) Intrarenal space-occupying lesions such as para-renal cysts, affecting normal stone removal; (3) Intraoperative ureteral stenting, ureteroscopic lithotripsy, percutaneous nephrolithotomy, open stone surgery, etc. in the past 3 months; (4) Uncontrolled systemic bleeding disorders, including ongoing use of anticoagulants, uncontrolled urinary tract infections or renal insufficiency (creatinine values greater than 265 umol/l), severe hip deformities, and difficulty in lithotomy; (5) Comorbidities that interfere with the participation or completion of the study, e.g. myocardial infarction, stroke, congestive heart failure, severe chronic respiratory lung disease, cancer, uncontrolled diabetes mellitus, pregnancy, severe systemic diseases or psychosis; (6) Those who have participated in other clinical trials within 3 months prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Stone free rate;

Secondary

MeasureTime frame
Operation time;Sheath placement success rate;Stage 2 surgery rate;Postoperative complications;Ureteral injury;

Countries

China

Contacts

Public ContactShusheng, Wang

Department of Urology, Guangdong Provincial Hospital of Chinese Medicine

shushengwanggzy@163.com+86 13512704335

Outcome results

None listed

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