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Prophylactic antibiotics for negative midstream urine culture patients before percutaneous nephrolithotomy: a single center randomized controlled clinical study

Prophylactic antibiotics for negative midstream urine culture patients before percutaneous nephrolithotomy: a single center randomized controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039396
Enrollment
Unknown
Registered
2020-10-25
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

infectious complications seccondary to PCNL

Interventions

A:a single dose prophylactic antibiotics prior to surgery
B:a day of prophylactic antibiotics prior to surgery
C:3 days of prophylactic antibiotics prior to surgery

Sponsors

Department of Urology, Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Percutaneous nephrolithotomy (PCNL) is recommended for those patients diagnosed as renal stones with CT, IVP or/and KUB. 2. Negative midstream urine culture prior to PCNL. 3. The presence of negative WBC+ and negative nitrite, or WBC- and negative nitrite in the urine. 4. the diameter of renal stones less than 4cm. 5. 18 < BMI < 28. 6. 18 <= age <= 75, without the restriction to gender. 7. Patients are willing and able to sign an informed consent form approved by an institutional review Committee (IRB), ethics Committee (EC) or Ethics Review Committee (ERB) before surgery. 8. The patients must be able to communicate, read and understand questions freely, and provide feedback in the appropriate translated language to the subject's subjective questionnaire as required in the study protocol.

Exclusion criteria

Exclusion criteria: 1. Being allergy to Ceftazidime. 2. Patients with ureteral calculi; patients are scheduled with PCNL combined with other surgical procedures; Renal insufficiency 4. Moderate and severe hydronephrosis on the affected side. 4. Abnormal procalcitonin before surgery. 5. Diabetics. 6. Immunosuppressive patients. 7. Uncontrolled systemic hemorrhagic disease, bleeding tendency, history of constitutional disease or current use of anticoagulants. 8. Paraplegia patients. 9. Patients who cannot tolerate surgical anesthesia. 10.ASA score is greater than 2; Diseases influencing the safety of the study design to participate in and influence study completion, such as myocardial infarction or stroke, congestive heart failure, severe chronic obstructive pulmonary disease, cancer, coronary heart disease, diabetes, severe renal insufficiency, pregnancy, severe systemic disease, and severe psychosis in the past 3 months. 11. Participating in other clinical studies. 12. Subject is not able to talk, read and understand the questions and is unable to complete the Subject subjective Questionnaire. 13. Subjects do not sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Complication;

Secondary

MeasureTime frame
Stone free rate;Operating time;Hospital length;

Countries

China

Contacts

Public ContactHequn Chen

Xiangya Hospital, Central South University

chenhequnxy@126.com13627313867

Outcome results

None listed

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