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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urolithiasis

Detailed Description

Flexible and navigable suction-assisted retrograde intrarenal surgery (FANS-RIRS) has emerged as a promising endourological technique for the management of upper urinary tract stones. By combining flexible ureteroscopy with an actively navigable suction ureteral access sheath, this technique may facilitate stone fragment evacuation, improve visualization, and potentially reduce intrarenal pressure during surgery. Despite these technical advantages, postoperative infectious complications, particularly postoperative fever, remain clinically relevant concerns after retrograde intrarenal surgery.

Preoperative urine testing is routinely performed in patients undergoing endourological stone surgery. In current clinical practice at our center, both urine routine analysis and urine culture are obtained before surgery. For patients without significant pyuria or other clinical evidence of active urinary tract infection, FANS-RIRS is usually performed without waiting for the final urine culture results. Standard perioperative antibiotic prophylaxis is administered, including one preoperative dose and one postoperative dose according to institutional practice. Under this real-world management pathway, the clinical significance of subsequently reported preoperative urine culture results remains unclear.

This prospective observational study is designed to evaluate whether preoperative urine culture results are associated with postoperative fever after FANS-RIRS. Consecutive eligible patients undergoing FANS-RIRS for upper urinary tract stones will be prospectively enrolled. Based on the final reported preoperative urine culture findings, patients will be categorized into urine culture-positive and urine culture-negative groups. Postoperative fever and other perioperative clinical outcomes will be recorded prospectively.

The primary objective of the study is to determine the association between preoperative urine culture status and the occurrence of postoperative fever in patients undergoing FANS-RIRS. The primary outcome is the incidence of postoperative fever during the early postoperative period. Secondary analyses will assess the relationship between urine culture status and other infectious outcomes, as well as explore potential clinical and perioperative risk factors for postoperative fever, including demographic characteristics, comorbidities, stone burden, laboratory findings, and operative variables.

As a prospective observational study, no intervention will be assigned by the investigators, and all diagnostic and therapeutic decisions will be made according to routine clinical practice. The findings of this study may help clarify the predictive value of preoperative urine culture in a real-world FANS-RIRS setting and provide evidence for perioperative infectious risk stratification and optimization of clinical management in patients undergoing endourological stone surgery.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• China
  • GuangGong
    • Guangzhou, GuangGong, China, 510500
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients with upper urinary tract stones who are scheduled to undergo flexible and navigable suction-assisted retrograde intrarenal surgery (FANS-RIRS) at the study center. All eligible participants will undergo routine preoperative urine routine analysis and urine culture before surgery. In accordance with institutional clinical practice, patients without significant pyuria or clinical evidence of active urinary tract infection will proceed to surgery without waiting for the final urine culture result. Participants will be prospectively enrolled and classified according to their final preoperative urine culture results for outcome analysis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Urine culture-positive cohort; Participants with a positive preoperative urine culture result before undergoing FANS-RIRS. These patients will receive routine perioperative management according to institutional practice, and postoperative outcomes, including postoperative fever, will be prospectively observed and recorded.
Urine culture-negative cohort; Participants with a negative preoperative urine culture result before undergoing FANS-RIRS. These patients will receive routine perioperative management according to institutional practice, and postoperative outcomes, including postoperative fever, will be prospectively observed and recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative fever	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.	Within 72 hours after surgery

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: urolithiasis; Urine culture; FANS-RIRS; Postoperative fever
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis
• Other Study ID Numbers: GYFYZJH20260331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Do not plan to share the IPD (research data) with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No