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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000038677 |
Receipt No. | 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 | 2019/11/25 |
Basic information | ||
Public title | The randomized study to evaluate whether the instruments for clearing laparoscope reduce the surgical stress in colorectal cancer surgery. | |
Acronym | The Randomized control study that the instruments for clearing laparoscope affect to the surgical stress. | |
Scientific Title | The randomized study to evaluate whether the instruments for clearing laparoscope reduce the multifaceted surgical stress in colorectal cancer surgery. | |
Scientific Title:Acronym | The Randomized control study that the instruments for clearing laparoscope affect to the multifaced surgical stress. | |
Region |
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Condition | ||
Condition | Colorectal Cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate whether instruments for clearing lens of laparoscope reduce the multifaceted surgical stress in the colorectal operation. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | To evaluate whether instruments for clearing lens of laparoscope reduce the multifaceted surgical stress in the colorectal operation. |
Key secondary outcomes | The duration of operation and the number of clearing lens of laparoscope |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Educational,Counseling,Training | |
Type of intervention |
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Interventions/Control_1 | Clearing lens of laparoscope using the warm saline and gaze | |
Interventions/Control_2 | Clearing lens of laparoscope using the instrument for clearing lens of laparoscope (OpClear) | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 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. |
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Key exclusion criteria | 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. |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Yokohama City University Medical Center | ||||||
Division name | Gastroenterological Center | ||||||
Zip code | 2320024 | ||||||
Address | 4-57 Urafunecho, Minaki-ku, Yokohama | ||||||
TEL | 045-261-5656 | ||||||
nabe-jun@comet.ocn.ne.jp |
Public contact | |||||||
Name of contact person |
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Organization | Yokohama City University Medical Center | ||||||
Division name | Gastroenterological Center | ||||||
Zip code | 2320024 | ||||||
Address | 4-57 Urafunecho, Minaki-ku, Yokohama | ||||||
TEL | 045-261-5656 | ||||||
Homepage URL | |||||||
yo-chan.634@nifty.com |
Sponsor | |
Institute | Yokohama City University Medical Center |
Institute | |
Department |
Funding Source | |
Organization | AMUKO |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Yokohama City University Hospital and Yokoasuka Kyosai Hospital |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Yokohama NEXT |
Address | 1-1-1 Fukuura, Kanazawa-ku, Yokohama |
Tel | 045-370-7949 |
ynextedu@yokohama-cu.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 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) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044070 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |