Unique ID issued by UMIN | UMIN000015436 |
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Receipt number | R000017950 |
Scientific Title | Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation |
Date of disclosure of the study information | 2014/11/01 |
Last modified on | 2021/10/29 09:16:47 |
Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation
Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation
Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation
Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation
Japan |
Rectal cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety and effectiveness of robot assisted surgery for curative rectal cancer
Safety,Efficacy
Exploratory
Explanatory
Phase II
Urinary dysfunction
(1) Rate of anastomotic leakage
(2) Erectile dysfunction
(3) Defecatory dysfunction
(4) Stress assessment of surgeon
(5) Operation time
(6) Completion rate of robot assisted surgery
(7) Overall survival
(8) Disease free survival
(9) Other side effects (exclude (1))
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
The rectal cancer operation by the robot assisted surgery using the da Vinci operation system
20 | years-old | <= |
80 | years-old | >= |
Male and Female
(1) Patients will undergo low anterior resection for rectal cancer.
(2) Patients expected to be curatively A.
(3) performance Status (ECOG) is either 0 or 1.
(4) BMI (body mass index) is under 30.
(5) Patients who fulfill all the conditions listed below
A) WBC level is greater or equal to 3,000/mm^3.
B) PLT level is greater or equal to 100,000/mm^3.
C) AST and ALT level are less than or equal to 100 IU/L.
D) T-Bil level are less than 2.0 g/dl.
E) Serum creatinine level are less than 1.5mg/dl.
(6) All details have been explained thoroughly to patients, and they have a full understanding of the study. Patients have agreed to participate in the study of their own will and have signed the letter of consent.
Patients
(1) who will undergo neo-adjuvant chemo-radiotherapy, or lateral pelvic lymph node dissection.
(2) with distant metastasis or dissemination
(3) with bulky tumor, that is over 5cm in diameter
(4) who who have undergone previous abdominal surgery, and developed severe abdominal adhesion.
(5) active multiple cancer
(6) who are or may be pregnant. Also, patients are or lactating.
(7) with psychosis
(8) prolonged steroid use
(9) who had cardiac infarction, or angina within 6 months.
(10) with uncontrolled blood pressure
(11) with diabetes mellitus and are using insulin, or with uncontrolled diabetes mellitus
(12) with respiratory disease who need a continuous oxygen supply
(13) patient who have been determined as inappropriate by the person in charge of the research.
26
1st name | Masakazu |
Middle name | |
Last name | Yamamoto |
Tokyo Women's Medical University
Department of Surgery, Institute of Gastroenterology
162-8666
8-1 Kawada-cho, Shinjuku-ku, Tokyo
03-3353-8111
yamamoto.ige@twmu.ac.jp
1st name | Takeshi |
Middle name | |
Last name | Ohki |
Tokyo Women's Medical University
Department of Surgery, Institute of Gastroenterology
162-8666
8-1 Kawada-cho, Shinjuku-ku, Tokyo
03-3353-8111
ohki.takeshi@twmu.ac.jp
Tokyo Women's Medical University Hospital
patient's own expenses
Other
Institutional Review Board, Tokyo Women's Medical University
8-1 Kawada-cho, Shinjuku-ku, Tokyo
03-3353-81111
krinri.bm@twmu.ac.jp
NO
2014 | Year | 11 | Month | 01 | Day |
Unpublished
21
Completed
2014 | Year | 09 | Month | 13 | Day |
2014 | Year | 09 | Month | 11 | Day |
2014 | Year | 11 | Month | 01 | Day |
2024 | Year | 03 | Month | 31 | Day |
2014 | Year | 10 | Month | 14 | Day |
2021 | Year | 10 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017950
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