JRCT ID: jRCTs052230008
Registered date:11/04/2023
Robot-assisted fluoroscopic-guided renal access for percutaneous nephrolitotomy in supine position.
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Urolithiasis |
Date of first enrollment | 11/04/2023 |
Target sample size | 94 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | RAF group (47 cases): Performing renal puncuture by ANT-X assisted fluoroscopic guidance during percutaneous nephrolithotomy. US group (47 cases): Performing renal puncuture by ultrasound guidance during percutaneous nephrolithotomy. |
Outcome(s)
Primary Outcome | Success rate of single renal puncture |
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Secondary Outcome | stone free rate, number of renal punctures, renal puncture time, fluoroscopic time and perioperative complications |
Key inclusion & exclusion criteria
Age minimum | >= 16age old |
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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 Wakayama Medical Hospital or 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 18 years old and older - obtained written informed consent from themselves and representatives if their age are between 16 and 17 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 | Yamashita Shimpei |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Shimpei Yamashita |
Address | 811-1 Kimiidera, Wakayama City, Wakayama, Japan Wakayama Japan 641-8509 |
Telephone | +81-73-441-0637 |
keito608@wakayama-med.ac.jp | |
Affiliation | Wakayama Medical University Hospital |
Scientific contact | |
Name | Shimpei Yamashita |
Address | 811-1 Kimiidera, Wakayama City, Wakayama, Japan Wakayama Japan 641-8509 |
Telephone | +81-9086505031 |
keito608@wakayama-med.ac.jp | |
Affiliation | Wakayama Medical University Hospital |