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

ConditionKidney Stones
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLanzhou University Second Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years and older with kidney stones who meet the surgical indications for RIRS;

Patients who have provided informed consent.

Disqualifiers

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;

Trial population

Adult patients (typically aged 18 years and older) diagnosed with renal and/or upper ureteral stones who are scheduled to undergo retrograde intrarenal surgery (RIRS) at the urology department.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: Negative Pressure Suction Sheath Group
Group B: Standard Ureteral Access Sheath Group

Trial outcomes

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

Other outcomes

Sponsors and contacts

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