Robotic assisted percutaneous nephrolithotomy study

Not Applicable

• Conditions: urolithiasis; renal stone

• Registration Number: JPRN-jRCTs042190074
• Lead Sponsor: Taguchi Kazumi

Brief Summary

In this study, we conducted a single-center, randomized controlled trial, evaluating the safety and efficacy of an AI-empowered robot-assisted device for percutaneous renal access compared with conventional ultrasound guidance. The subjects were patients underwent percutaneous nephrolithotomy due to large renal stones. The study included each 30-cases in the ultrasound or robot group. No differences were seen in the primary and secondary endpoints between the two groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-21
• Study Completion: 2021-12-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Patients whose age are between 16 and 80 years old, diagnosed with renal and/or upper ureteral stone at Nagoya City University Hospital, and planned for percutaneous nephrolithotomy
2) Stones for 15mm and larger in size
3) Patients who were obtained written informed consent
- obtained written informed consent from themselves if they are 20 years old and older
- obtained written informed consent from themselves and representatives if their age are between 16 and 19 years old

Exclusion Criteria

A) women with pregnant or its possibility
B) having active pyelonephritis
C) under anti-platelet/coagulation therapy within 1 week prior surgery
D) difficult status for general/lumber anesthesia judged by anesthesiologist
E) Best supportive care due to terminal carcinoma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.success rate of inserting puncture needle from skin to anaimed renal calyx<br>2.success rate of nephrostomy access for renal collecting system with nephroscope

Secondary Outcome Measures

Name	Time	Method
renal puncture time, fluoroscopic time, total operation time, perioperational complicationrate (hemorrhage needed transfusion, pulmonary embolism, fever more than 38 c degree, SIRS, ureteral injury, other organ injury), length of hospitalization