Menu
Recruiting NCT07492147

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

Observational Kidney Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Kidney Stones. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

The goal of this observational study is to learn about the effects of using negative pressure suction during retrograde intrarenal surgery (RIRS) in patients aged 18 and older with kidney stones. The main questions it aims to answer are: 1. Does using negative pressure suction during surgery affect the amount of irrigation fluid absorbed by the patient's body? 2. Does using negative pressure suction reduce the risk of postoperative infections, such as fever, systemic inflammatory response syndrome (SIRS), and urosepsis? Researchers will compare patients who undergo surgery with a negative pressure suction sheath to patients who undergo surgery with a standard sheath (without suction) to see if the suction technology reduces fluid absorption and lowers the risk of postoperative complications. Participants will undergo their scheduled kidney stone surgery as part of their regular medical care. Researchers will collect their routine clinical data from the hospital system, including: 1. Preoperative test results (such as CT scans, ultrasounds, and urine tests). 2. Intraoperative data (such as surgery duration and the exact amount of fluid absorbed, measured by a monitoring device). 3. Postoperative recovery data (such as body temperature, pain levels, hospital stay length, and any signs of infection).

Primary outcome measures

  • Volume of irrigation fluid absorbed [Time frame: Intraoperative (During the surgery)]
Secondary outcome measures (3)
  • Incidence of postoperative fever and infectious complication [Time frame: Up to 7 days postoperatively]
  • ostoperative length of hospital stay [Time frame: From surgery to hospital discharge (an average of 3-7 days)]
  • Stone-free rate (SFR) [Time frame: 1 month postoperatively]

Eligibility criteria

Inclusion criteria

  • Patients aged 18 years and older with kidney stones who meet the surgical indications for RIRS;
  • Patients who have provided informed consent.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Lanzhou University Second Hospital — Lanzhou

Identifiers

NCT: NCT07492147 · 2025A-1369

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗