Antibiotic-Free kidney stone surgery: a game changer?
NCT ID NCT07246967
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether it's safe to skip antibiotics before a specific type of kidney stone surgery in patients at low risk for infection. The surgery uses a special suction tool to remove stones. Researchers will compare infection rates between those who get antibiotics and those who don't, involving 500 adults aged 18-75 with small kidney stones.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-75 years. 2. Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being ≤2cm. 3. Scheduled to undergo fURS lithotripsy. 4. No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative. 5. No immunosuppressive status and no urinary flow obstruction caused by anatomical abnormalities. 6. No use of long-acting antimicrobial agents within 7 days prior to surgery, and no use of intermediate or short-acting antimicrobial agents within 72 hours prior to surgery. 7. Has signed and dated an informed consent form, indicating that the patient or their legal representative has been fully informed about the study-related information and has agreed to participate. Exclusion Criteria: 1. Pregnant or lactating women. 2. Allergy to the investigational drug(s). 3. Participation in other clinical trials within 30 days. 4. Presence of other active infection foci requiring antimicrobial treatment. 5. Concomitant severe systemic diseases, such as cardiac or pulmonary disease, malignant tumors, and immunodeficiency states. 6. Congenital malformations of the urinary tract. 7. History of kidney transplantation or urinary diversion surgery. 8. Unable to provide samples or complete follow-up according to the study protocol. 9. Unable to provide informed consent. 10. Inability to achieve complete placement of the flexible negative-pressure suction sheath. 11. Any other conditions that the investigator deems unsuitable for participation in this study. 12. History of diabetes mellitus, immunocompromised. 13. Renal insufficiency, neurogenic bladder. 14. Recent preoperative history of stone-related fever. 15. Long-term indwelling urinary drainage tube. 16. Urine white blood cells \>5/HPF (High Power Field) or positive for urine nitrites. 17. Large stone burden (e.g., staghorn calculus) or moderate to severe hydronephrosis. 18. Imaging findings showing turbid urine in the renal pelvis where pyonephrosis or infectious stones cannot be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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Shanghai General Hospital
RECRUITINGShanghai, Shanghai Municipality, 200080, China
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Other studies related to the condition(s) this trial covers.
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