Actively Recruiting

Age: 18Years +
All Genders
ID07492147

Impact of Negative Pressure Suction on Irrigation Fluid Absorption and Postoperative Infection Risk During Flexible Ureteroscopic Lithotripsy: A Prospective Cohort Study

Led by Lanzhou University Second Hospital · Updated on 2026-03-25

400

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to learn about the effects of using negative pressure suction during retrograde intrarenal surgery (RIRS) in adults aged 18 and older with kidney stones. It focuses on whether this suction method affects how much irrigation fluid is absorbed during surgery and if it lowers the risk of postoperative infections like fever, systemic inflammatory response syndrome (SIRS), and urosepsis. The study compares patients who have surgery with a negative pressure suction sheath to those using a standard sheath without suction. Participants will undergo their scheduled kidney stone surgery as part of their usual care. The study groups include those receiving surgery with a negative pressure suction sheath and those with a standard ureteral access sheath. During surgery, researchers will monitor details such as surgery duration and the volume of irrigation fluid absorbed using a monitoring device. Throughout the study, researchers will collect clinical data including preoperative tests (CT scans, ultrasounds, urine tests), intraoperative data, and postoperative recovery information like body temperature, pain levels, hospital stay length, and any infections. The main outcome measured is the volume of irrigation fluid absorbed during surgery, along with secondary outcomes like incidence of postoperative fever or infection within 7 days, length of hospital stay, and stone-free status one month after surgery.

CONDITIONS

Brief Title

Effect of Negative Pressure Suction on Fluid Absorption and Infection in Flexible Ureteroscopy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years and older with kidney stones who meet the surgical indications for RIRS
  • Patients who have provided informed consent
Not Eligible

You will not qualify if you...

  • Concurrent combination with other surgical procedures, such as percutaneous nephrolithotomy (PCNL)
  • Patients with malignancies, urinary tuberculosis, immune system diseases, or hyperthyroidism
  • Congenital renal anomalies, such as polycystic kidney disease or horseshoe kidney
  • Presence of untreated urinary tract infections
  • Inability to tolerate surgery due to severe cardiopulmonary dysfunction, hepatic or renal insufficiency, or coagulation abnormalities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and hospital stay of approximately 3 to 7 days

Participants undergo flexible ureteroscopic lithotripsy with either a negative pressure suction sheath or a standard ureteral access sheath and receive immediate post-operative monitoring.

1 surgery visit and daily in-hospital visits for up to 7 days

Post-operative Follow-up

Duration - Up to 1 month after surgery

Participants are monitored for postoperative fever, infectious complications, and stone-free status.

1 follow-up visit at 1 month postoperatively

Trial Site Locations

Total: 1 location

1

Lanzhou University Second Hospital

Lanzhou, Gansu, China, 730030

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Research Team

Z

Zhiping Wang

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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