Evaluating the Efficacy of Litho Vue Elite for ECIRS

JRCT ID: jRCTs042240139

Registered date:09/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: upper tract urinary calculi
• Date of first enrollment: 09/12/2024
• Target sample size: 150
• Study type: Interventional
• Intervention(s): This randomised study aimed to evaluate the efficacy of intraoperative IPP monitoring on postoperative infection of ECIRS comparing LithoVue Elite to LithoVue.

Outcome(s)

• Primary Outcome: Incidence of postoperative fever (a temperature >38.5 for at least 1 day or >38.0 for more than 2 days) during hospitalization

Secondary Outcome

1. Surgical time
2. Total time with excessive IRP (>30mmHg)
3. Number of SIRS criteria (Body temperature, Herat rate, Respiratory rate, WBC)
4. quick SOFA (qSOFA:Respiratory rate, Altered mental status, Systolic BP)
5. Intraoperative inflammatory markers (WBC, CRP)
6. Number of times postoperative analgesics used
7. Postoperative Inflammatory marker (WBC, CRP)
8. Stone free rate
9. Postoperative complications (Clavien Dindo Classification)
10. Wisconsin QOL score

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. Patients who will be performed ECIRS for upper tract urinary calculi at the Nagoya City University Hospital or Ngaoya City University East Medical Center
2. Age at the time of informed consent is between 25 and 85 years old
3. Written informed consent from patient to participate in the study, including compliance with study procedures

Exclude criteria

1. Patients with coagulation abnormality or unable to discontinue anticoagulants
2. Pregnant or possibly pregnant or breastfeeding women
3. Patients who are not be able to do general anesthesia
4. Patients unable to maintain the surgical position (prone split-leg position)
5. Patients with active febrile urinary tract infection
6. Patients after urinary diversion
7. Patients with preoperative nephrostomy insertion
8. Patients who cannot be inserted ureteroscopy due to severe ureteral stricture
9. Other patients for whom the investigator or sub-investigator judges the subject to be inappropriate

Related Information

• Primary Sponsor: Hamamoto Shuzo
• Source(s) of Monetary Support: Boston Scientific Japan