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NCT Number: NCT07492147

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location status: Recruiting

Location contact

Guilin Wang

CONTACT

[email protected]

18386255271

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Volume of irrigation fluid absorbed

    Time frame: Intraoperative (During the surgery)

Secondary outcomes

  1. Incidence of postoperative fever and infectious complication

    Time frame: Up to 7 days postoperatively

  2. ostoperative length of hospital stay

    Time frame: From surgery to hospital discharge (an average of 3-7 days)

  3. Stone-free rate (SFR)

    Time frame: 1 month postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Zhiping Wang

CONTACT

[email protected]

13893131697

Sponsors and collaborators

Lead sponsor

Lanzhou University Second Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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