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

March 19, 2026 updated by: Zhiping Wang, Lanzhou University Second Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Recruiting
        • Lanzhou University Second Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Negative Pressure Suction Sheath Group
Patients who undergo retrograde intrarenal surgery (RIRS) using a ureteral access sheath with a negative pressure suction system.
Standard Ureteral Access Sheath Group
Patients who undergo retrograde intrarenal surgery (RIRS) using a standard ureteral access sheath without a negative pressure suction system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Volume of irrigation fluid absorbed
Time Frame: Intraoperative (During the surgery)
Intraoperative (During the surgery)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative fever and infectious complication
Time Frame: Up to 7 days postoperatively
Up to 7 days postoperatively
ostoperative length of hospital stay
Time Frame: From surgery to hospital discharge (an average of 3-7 days)
From surgery to hospital discharge (an average of 3-7 days)
Stone-free rate (SFR)
Time Frame: 1 month postoperatively
1 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lanzhou University Second Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 7, 2027

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025A-1369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The clinical data involves sensitive patient privacy. We are currently undecided on sharing the IPD, as it requires specific informed consent from the patients and authorization from the hospital's ethics committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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