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Active, not recruiting Observational

Predictive Value of Preoperative Urine Culture for Postoperative Fever After FANS-RIRS When Surgery Proceeds Before Culture Results Are Available

NCT07514676 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-04-01
Last updated
2026-04-07

Condition(s) studied

Urolithiasis

Study summary

This prospective observational study aims to investigate whether preoperative urine culture results are associated with the incidence of postoperative fever in patients undergoing flexible and navigable suction-assisted retrograde intrarenal surgery (FANS-RIRS). In current clinical practice at our center, urine routine analysis and urine culture are both performed before admission. For patients without significant pyuria or other clinical signs of active infection, surgery is performed without waiting for the final urine culture results, and standard perioperative antibiotic prophylaxis is administered.

Based on the final reported preoperative urine culture results, enrolled patients will be classified into different groups, and postoperative febrile outcomes will be prospectively recorded and compared. The primary outcome is the occurrence of postoperative fever within the early postoperative period. Relevant demographic, clinical, stone-related, laboratory, and perioperative variables will also be collected to explore potential risk factors for postoperative fever.

The study is designed to evaluate the predictive value of preoperative urine culture in a real-world FANS-RIRS pathway and to provide evidence for perioperative infectious risk stratification and management in patients undergoing endourological stone surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Adult patients aged 18 years or older * Patients diagnosed with upper urinary tract stones and scheduled to undergo FANS-RIRS * Patients who have completed preoperative urine routine analysis and urine culture before surgery * Patients without significant pyuria or clinical evidence of active urinary tract infection at the time of surgery, and therefore managed according to the routine institutional pathway * Patients who are able and willing to provide informed consent Exclusion Criteria: * Age younger than 18 years * Patients with preoperative fever or clinical evidence of active urinary tract infection requiring delayed surgery or additional treatment * Patients with sepsis or severe infection before surgery * Patients undergoing combined or alternative surgical procedures other than FANS-RIRS alone * Patients with missing or unavailable preoperative urine culture results * Patients with incomplete perioperative or postoperative clinical data * Patients who decline to participate or withdraw informed consent

Primary outcome measure(s)

  • Incidence of postoperative fever — Within 72 hours after surgery
    The primary outcome is the occurrence of postoperative fever after FANS-RIRS. Postoperative fever will be defined as a body temperature of at least 38.0°C recorded during the early postoperative period.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Guangzhou Medical University Guangzhou GuangGong
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07514676 on ClinicalTrials.gov ↗ ← All trials in China