Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath

NCT07246967 | Recruiting

• 1 other identifier: IIT2025-208
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. It is anticipated that this will have a substantial impact on infection prevention strategies in urological surgery.

Conditions

Urolithiasis; Antibiotics

Outcome Measures

Primary Outcomes (1)

• the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively

  To reduce the influence of subjective factors and to more comprehensively reflect the systemic inflammatory state, the primary endpoint is the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively, defined as meeting at least two of the following criteria: Body temperature \>38°C or \<36°C Heart rate \>90 beats/minute Respiratory rate \>20 breaths/minute or PaCO2 \<32 mmHg White blood cell count \>12×10⁹/L or \<4×10⁹/L, or \>10% immature neutrophils

  within 72 hours postoperatively

Study Arms (2)

Group 1

EXPERIMENTAL

Undergo flexible ureteroscopic lithotripsy and stone clearance with a flexible negative-pressure sheath without the use of any prophylactic antimicrobials; postoperatively, therapeutic antimicrobials will be initiated only for patients who develop signs or symptoms of infection.

Drug: not use any prophylactic antimicrobials

Group 2

ACTIVE COMPARATOR

Receive a single dose of intravenous prophylactic antimicrobials (e.g., a second-generation cephalosporin or levofloxacin) 30-60 minutes before surgery, followed by the same standardized flexible negative-pressure sheath ureteroscopic surgery.

Drug: use prophylactic antimicrobials

Interventions

use prophylactic antimicrobials DRUG

Receive a single dose of intravenous prophylactic antimicrobials (e.g., a second-generation cephalosporin or levofloxacin) 30-60 minutes before surgery, followed by the same standardized flexible negative-pressure sheath ureteroscopic surgery.

Also known as: apply antimicrobial drugs for prophylaxis

Group 2

not use any prophylactic antimicrobials DRUG

The experimental group will undergo surgery without the use of any prophylactic antimicrobials; therapeutic antimicrobials will only be administered postoperatively to patients who develop signs or symptoms of infection. The control group will receive a single dose of intravenous prophylactic antimicrobials 30-60 minutes before surgery, followed by the same standardized surgical procedure.

Also known as: without the use of any antimicrobial drugs for prophylaxis

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years.
• Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being ≤2cm.
• Scheduled to undergo fURS lithotripsy.
• No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative.
• No immunosuppressive status and no urinary flow obstruction caused by anatomical abnormalities.
• 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.
• 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.

You may not qualify if:

• Pregnant or lactating women.
• Allergy to the investigational drug(s).
• Participation in other clinical trials within 30 days.
• Presence of other active infection foci requiring antimicrobial treatment.
• Concomitant severe systemic diseases, such as cardiac or pulmonary disease, malignant tumors, and immunodeficiency states.
• Congenital malformations of the urinary tract.
• History of kidney transplantation or urinary diversion surgery.
• Unable to provide samples or complete follow-up according to the study protocol.
• Unable to provide informed consent.
• Inability to achieve complete placement of the flexible negative-pressure suction sheath.
• Any other conditions that the investigator deems unsuitable for participation in this study.
• History of diabetes mellitus, immunocompromised.
• Renal insufficiency, neurogenic bladder.
• Recent preoperative history of stone-related fever.
• Long-term indwelling urinary drainage tube.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yi Shao

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziyang Zheng

CONTACT

18861968196; zhengzzy0116@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the trial is completed

Locations

CN (1)