UrolithiasisNCT07514676
Predictive Value of Preoperative Urine Culture for Postoperative Fever After FANS-RIRS When Surgery Proceeds Before Culture Results Are Available
An observational study of Urolithiasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urolithiasis
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Jul 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, GuangGong, 510500
About this study
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.
Read the 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.
- Conditions
- Urolithiasis
- Keywords
- FANS-RIRS, Urine culture, Postoperative fever, urolithiasis
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Apr 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junhao Zheng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514676
- Sponsor's protocol ID
- GYFYZJH20260331
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Do not plan to share the IPD (research data) with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Preoperative Urine Culture for Postoperative Fever After FANS-RIRS When Surgery Proceeds Before Culture Results Are Available
- ClinicalTrials.gov ID
- NCT07514676
- Acronym / sponsor ID
- GYFYZJH20260331
- Conditions
- Urolithiasis
- Keywords
- FANS-RIRS, Urine culture, Postoperative fever, urolithiasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative fever
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No. Do not plan to share the IPD (research data) with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative fever (time frame: Within 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.