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Prospective randomized control trial analyzing the efficacy of LithoVue Elite on postoperative infection of endoscopic combined intrarenal surgery (ECIRS) (Elite ECIRS-2023)

Evaluating the Efficacy of Litho Vue Elite for ECIRS (Elite ECIRS-2023)

Hamamoto Shuzo

Nagoya City University Hospital

1, Kawasumi, Mizuho-chou, Mizuho-ku, Nagoya, Aichi

hamamo10@med.nagoya-cu.ac.jp

Hamamoto Shuzo

Nagoya City University Hospital

1, Kawasumi, Mizuho-chou, Mizuho-ku, Nagoya, Aichi

+81-52-853-8266

hamamo10@med.nagoya-cu.ac.jp

Recruiting

Dec. 09, 2024

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

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

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

Both

upper tract urinary calculi

This randomised study aimed to evaluate the efficacy of intraoperative IPP monitoring on postoperative infection of ECIRS comparing LithoVue Elite to LithoVue.

Kidney calculi

ECIRS, Intrarenal pressure, Litho Vue Elite

D007669

D000074642

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

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

+81-52-853-8346

Mar. 12, 2024

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