Robotic assisted percutaneous nephrolithotomy study

JRCT ID: jRCTs042190074

Registered date:21/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: urolithiasis
• Date of first enrollment: 20/01/2020
• Target sample size: 60
• Study type: Interventional

Intervention(s)

RAF group (30 cases): Performing renal puncuture by ANT-X assisted fluoroscopic guidance during percutaneous nephrolithotomy.
US group (30 cases): Performing renal puncuture by ultrasound guidance during percutaneous nephrolithotomy.

Outcome(s)

Primary Outcome

1.success rate of inserting puncture needle from skin to anaimed renal calyx
2.success rate of nephrostomy access for renal collecting system with nephroscope

• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Taguchi Kazumi