Unique ID issued by UMIN | UMIN000028133 |
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Receipt number | R000032168 |
Scientific Title | Clinical study for Robot-assisted partial nephrectomy with da Vinci Si |
Date of disclosure of the study information | 2017/08/01 |
Last modified on | 2019/08/14 15:54:26 |
Clinical study for Robot-assisted partial nephrectomy with da Vinci Si
Clinical study for Robot-assisted partial nephrectomy
Clinical study for Robot-assisted partial nephrectomy with da Vinci Si
Clinical study for Robot-assisted partial nephrectomy
Japan |
Renal Cell Carcinoma
Urology |
Malignancy
NO
We examine the effectiveness and safety of Robot-ssited partial nephrectomy using daVinci Si system.
Safety,Efficacy
intra-and postoperative complications and its contents
Time of general anesthesia, operation time, bleeding, renal ischemic time, frequency of postoperative analgesic use, postoperative hospitalization period, perioperative renal function (before surgery (pre-operative surgery 12 weeks before),the day before surgery, on the day of the surgery, the day after surgery, the surgery three days after, the surgery six days later, after one month, three months after surgery)serum creatinine, eGFR), and before surgery (pre-operative surgery 12 weeks before), the day of one month, three months after surgery of renal scintigraphy), pathology findings
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Device,equipment | Maneuver |
Diagnosed with renal cell carcinoma and the clinical stage T1a (tumors less than 4 cm) N0M0 or T1b (diameter 4 cm to 7 cm), solitary tumors should be performed robot-assited partial nephrectomy under da Vinci SI.
20 | years-old | <= |
Not applicable |
Male and Female
1. diagnosed with renal cell carcinoma and the clinical stage T1a (tumors less than 4 cm) N0M0 or T1b (diameter 4 cm to 7 cm), solitary tumors allows partial resection.
2. age of 20 years or more.
3. written informed consent obtained from the individual persons.
1. the patient seems to be difficult to surgery due to previous surgery.
2. activity of heavy multiple cancer among patients.
3.6 months undergoing treatment for kidney cancer.
4. patients with possible discontinuation of anticoagulants.
5. patients requiring blood transfusion anemia or tendency of bleeding.
6. morbid obesity (BMI35 or higher)
7. kidney transplantation history.
8. dialysis patients.
9. pregnant women or pregnant or lactating women
10. patients with a mental illness or psychiatric symptoms.
11. patients have serious complications (angina pectoris, myocardial infarction, serious arrhythmias, uncontrolled diabetes, malignant hypertension, etc.), surgical treatment is difficult.
12. patients who have renal dysfunction (serum creatinine values:1.5mg/dl more), liver function (AST, ALT:100IU/l).
13. patients with bacterial infections require treatment.
14. patients with interstitial Pneumonitis or pulmonary fibrosis.
15. patients with severe drug hypersensitivity, drug allergies.
16. patients with under 20 years old.
17. patient deemed unfit for this protocol.
10
1st name | Tomoaki |
Middle name | |
Last name | Miyagawa |
Jichi Medical University, Saitama Medical Center
Department of Urology
3308503
1-847, Amanuma-cho, Omiya-ku, Saitama City, Saitama, Japan
048-647-2111
sh2-mya@jichi.ac.jp
1st name | Tomoaki |
Middle name | |
Last name | Miyagawa |
Jichi Medical University, Saitama Medical Center
Department of Urology
3308503
1-847, Amanuma-cho, Omiya-ku, Saitama City, Saitama, Japan
048-647-2111
sh2-mya@jichi.ac.jp
Jichi Medical University, Saitama Medical Center
Jichi Medical University, Saitama Medical Center
Other
Jichi Medical University Saitama Medical Center
1-847 Amanuma-cho Omiya-ku Saitama City Saitama Japan
0486472111
sh2-mya@jichi.ac.jp
NO
2017 | Year | 08 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 06 | Month | 01 | Day |
2017 | Year | 06 | Month | 01 | Day |
2017 | Year | 08 | Month | 01 | Day |
2020 | Year | 03 | Month | 31 | Day |
2017 | Year | 07 | Month | 07 | Day |
2019 | Year | 08 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032168
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