Unique ID issued by UMIN | UMIN000034236 |
---|---|
Receipt number | R000039021 |
Scientific Title | A pilot study of robot assisted colorectal cancer surgery using the da Vinci Si surgical system |
Date of disclosure of the study information | 2018/09/25 |
Last modified on | 2018/09/21 21:36:26 |
A pilot study of robot assisted colorectal cancer surgery using the da Vinci Si surgical system
A pilot study of robot assisted colorectal cancer surgery using the da Vinci Si surgical system
A pilot study of robot assisted colorectal cancer surgery using the da Vinci Si surgical system
A pilot study of robot assisted colorectal cancer surgery using the da Vinci Si surgical system
Japan |
Rectal cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety of robot assisted resection of primary colorectal cancer using the da Vinci Si surgical system
Safety
The conversion rate to open surgery
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
robot-assisted colorectal cancer surgery using the da Vinci Si Surgical System
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1. Pathologically confirmed colorectal cancer
2. Patient has no distant metastases
3. Patient age is more than 20 years old, less than 80 years old.
4. Performance status is 0 or 1.
5. Tumor without invasion to other organ
6. Informed consent by a document is acquired.
1. Mental disorder
2. Platelet less than 50,000/ul or PT(prothrombin time) less than 80%
3. Liver dysfunction (AST, ALT: more than 100 IU/l)
4. Renal disfunction (eGFR : less than 29ml/min)
5. Severe cardiac dysfunction (Ejection Fraction less than 30%)
6. Severe adhesion is expected by past operations
7. Blood transfusion is not permitted
8. The attending physician decides that the patient is unfit for this study
10
1st name | |
Middle name | |
Last name | Tomomichi Kiyomatsu |
National Center for Global Health and Medicine
Devision of Coloproctology
1-21-1, Toyama, Shinjyuku-ku, Tokyo
03-3202-7181
kiyomatan@yahoo.co.jp
1st name | |
Middle name | |
Last name | Tomomichi Kiyomatsu |
National Center for Global Health and Medicine
Devision of Coloproctology
1-21-1, Toyama, Shinjyuku-ku, Tokyo
03-3202-7181
kiyomatan@yahoo.co.jp
National Center for Global Health and Medicine
National Center for Global Health and Medicine
Other
NO
2018 | Year | 09 | Month | 25 | Day |
Unpublished
Open public recruiting
2017 | Year | 12 | Month | 26 | Day |
2018 | Year | 02 | Month | 28 | Day |
2018 | Year | 09 | Month | 21 | Day |
2018 | Year | 09 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039021