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临床试验/NCT07492147
NCT07492147招募中不适用

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

Lanzhou University Second Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Volume of irrigation fluid absorbed

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Volume of irrigation fluid absorbed

时间窗: Intraoperative (During the surgery)

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhiping Wang

Professor; Chief Physician

Lanzhou University Second Hospital

研究点 (1)

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