UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038677 |
|---|---|
| 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 |
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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
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
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
| Device,equipment |
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
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.
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.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
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
| 1st name | Sho |
| Middle name | |
| Last name | Sato |
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
shosato@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
rinri@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
| 2019 | Year | 12 | Month | 01 | Day |
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
Results date posted
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
| 2019 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 25 | Day |
Last modified on
| 2020 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044070
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