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Comparison of the safety and effectiveness of nephrostomy sheath with suction function and Peel-away sheath in percutaneous nephrolithotomy

Comparison of the safety and effectiveness of nephrostomy sheath with suction function and Peel-away sheath in percutaneous nephrolithotomy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039681
Enrollment
Unknown
Registered
2020-11-05
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Kidney stones

Interventions

Experimental group:nephrostomy sheath with suction function
Control group:18FrPeel-away sheath

Sponsors

The Fifth Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old, diagnosed as 20-40mm kidney stones by upper urinary tract CT; 2. Kidney stones with a total diameter of 20-40mm, occupying the renal pelvis and one calyx, may be accompanied by mild to moderate hydronephrosis; 3. Renal function is normal, no abnormal renal anatomy and history of open surgery; 4. ASA score I and II; 5. preoperative urinary tract infection is well controlled.

Exclusion criteria

Exclusion criteria: 1. Uncontrollable systemic hemorrhagic disease; 2. Severe cardiopulmonary insufficiency, renal insufficiency, uncontrolled diabetes, hypertension patients; 3. Patients with uncontrollable fever before and during the operation; 4. Scoliosis Malformation, horseshoe kidney, duplication kidney, ectopic kidney, malrotation and other anatomical abnormalities; 5. Patients with severe hydronephrosis; 6. Patients with urinary tuberculosis, renal tumors, and history of kidney transplantation; 7. Intraoperative blood pressure fluctuations Obvious, severe hemorrhage and pyelemia.

Design outcomes

Primary

MeasureTime frame
Blood routine;Urine routine;Urine bacterial culture;Coagulation;Procalcitonin;Renal function;CT of upper urinary tract;ECG;ASA score;Intraoperative renal pelvic pressure;Time to remove the stone;Remove stone volume;Stone composition;Hospital stay;

Countries

China

Contacts

Public ContactXu Guibin

The Fifth Affiliated Hospital of Guangzhou Medical University

gyxgb@163.com+86 13602432800

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026