Unique ID issued by UMIN | UMIN000031647 |
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Receipt number | R000036135 |
Scientific Title | Pilot study of robot-assisted rectal cancer surgery using the da Vinci Xi Surgical System |
Date of disclosure of the study information | 2018/04/01 |
Last modified on | 2021/03/11 11:31:29 |
Pilot study of robot-assisted rectal cancer surgery using the da Vinci Xi Surgical System
Pilot study of robot-assisted rectal cancer surgery
Pilot study of robot-assisted rectal cancer surgery using the da Vinci Xi Surgical System
Pilot study of robot-assisted rectal cancer surgery
Japan |
Rectal cancer
Gastrointestinal surgery |
Malignancy
NO
To study of the feasibility or safety of robot-assisted rectal cancer surgery using the da Vinci Xi surgical system
Safety,Efficacy
The rate of adverse events during and after robotic surgery
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
robot-assisted rectal cancer surgery using the da Vinci Xi Surgical System
20 | years-old | <= |
75 | years-old | > |
Male and Female
1. Localization of tumor is RS, Ra, and Rb.
2. Curability A operation is expected.
3. Patient age is more than 20 years old, less than 75 years old.
4. ECOG performance status is 0 or 1.
5. Patient is possible to take orally.
6. Informed consent by a document is acquired.
1. Robot-assisted surgery is difficult by the operation past, or last operation findings.
2. Severe complication(angina, myocardial infarction, severe arrhythmia, poor control diabetes mellitus, malignant hyperthermia, bleeding tendency, etc.)
3. Anemia (Hb: less than 9.0g/dl)
4. Renal disfunction (serum creatinine: more than 1.5mg/dl),
5. Liver dysfunction (AST, ALT: more than 100 IU/l)
6. Interstitial pneumonia, pulmonary fibrosis, severe emphysema
7. Severe drug sensitivity, drug allergy
8. Glaucoma
9. Post subarachnoid hemorrhage, unruptured cerebral aneurysm
10. Mental disorder
11. The attending physician decides that the patient is unfit for this surgery
10
1st name | |
Middle name | |
Last name | Atsushi Tsuruta |
Kawasaki Medical School
Department of Digestive Surgery
577 Matsushima, Kurashiki, Okayama
086-462-1111
atsuatsu@apost.plala.or.jp
1st name | |
Middle name | |
Last name | Atsushi Tsuruta |
Kawasaki Medical School
Department of Digestive Surgery
577 Matsushima, Kurashiki, Okayama
086-462-1111
atsuatsu@apost.plala.or.jp
Department of Digestive Surgery, Kawasaki Medical School
Department of Digestive Surgery, Kawasaki Medical School
Other
NO
2018 | Year | 04 | Month | 01 | Day |
Unpublished
Terminated
2018 | Year | 04 | Month | 01 | Day |
2018 | Year | 10 | Month | 29 | Day |
2018 | Year | 04 | Month | 01 | Day |
2020 | Year | 12 | Month | 31 | Day |
2018 | Year | 03 | Month | 09 | Day |
2021 | Year | 03 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036135
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