Unique ID issued by UMIN | UMIN000038677 |
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Receipt number | R000044070 |
Scientific Title | The randomized study to evaluate whether the instruments for clearing laparoscope reduce the multifaceted surgical stress in colorectal cancer surgery. |
Date of disclosure of the study information | 2019/12/01 |
Last modified on | 2020/12/01 20:07:48 |
The randomized study to evaluate whether the instruments for clearing laparoscope reduce the surgical stress in colorectal cancer surgery.
The Randomized control study that the instruments for clearing laparoscope affect to the surgical stress.
The randomized study to evaluate whether the instruments for clearing laparoscope reduce the multifaceted surgical stress in colorectal cancer surgery.
The Randomized control study that the instruments for clearing laparoscope affect to the multifaced surgical stress.
Japan |
Colorectal Cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate whether instruments for clearing lens of laparoscope reduce the multifaceted surgical stress in the colorectal operation.
Efficacy
Confirmatory
Explanatory
Not applicable
To evaluate whether instruments for clearing lens of laparoscope reduce the multifaceted surgical stress in the colorectal operation.
The duration of operation and the number of clearing lens of laparoscope
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Educational,Counseling,Training
Device,equipment |
Clearing lens of laparoscope using the warm saline and gaze
Clearing lens of laparoscope using the instrument for clearing lens of laparoscope (OpClear)
20 | years-old | <= |
Not applicable |
Male and Female
Incursion criteria for a patient
(1)diagnosed colorectal cancer
(2)the patients are planned laparoscopic surgery for colorectal cancer.
(3) the patients totally understand this research
(4)the patients with accepting consent to participate in this study
Incursion criteria for a doctor
(1)Physician who can perform laparoscopic colectomy and the main operator of laparoscopic colectomy for colorectal cancer.
exclusion criteria for patients
(1)Patients who aren't able to totally understand this study
(2)the patients are planned the lateral lymph node dissection
(3)BMI>35
(4)Patients who are pregnant, may be pregnant, or wish to be pregnant during treatment.
(5) the patients are participated in another clinical trials at the same time or within 30 days before participation in this trial.
(6) The patients who are judged to be inappropriate for this study by a doctor.
exclusion criteria for a doctor
(1) The Surgeons have had less than 5 cases of laparoscopic colorectal resection.
120
1st name | Jun |
Middle name | |
Last name | Watanabe |
Yokohama City University Medical Center
Gastroenterological Center
2320024
4-57 Urafunecho, Minaki-ku, Yokohama
045-261-5656
nabe-jun@comet.ocn.ne.jp
1st name | Sho |
Middle name | |
Last name | Sato |
Yokohama City University Medical Center
Gastroenterological Center
2320024
4-57 Urafunecho, Minaki-ku, Yokohama
045-261-5656
shosato@yokohama-cu.ac.jp
Yokohama City University Medical Center
AMUKO
Profit organization
Yokohama City University Hospital and Yokoasuka Kyosai Hospital
Yokohama NEXT
1-1-1 Fukuura, Kanazawa-ku, Yokohama
045-370-7949
rinri@yokohama-cu.ac.jp
NO
横浜市立大学附属市民総合医療センター(神奈川県)、横浜市立大学附属病院(神奈川県)、横須賀共済病院 (神奈川県)
2019 | Year | 12 | Month | 01 | Day |
Unpublished
Preinitiation
2019 | Year | 11 | Month | 06 | Day |
2019 | Year | 11 | Month | 13 | Day |
2019 | Year | 12 | Month | 01 | Day |
2020 | Year | 06 | Month | 30 | Day |
2019 | Year | 11 | Month | 25 | Day |
2020 | Year | 12 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044070
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