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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

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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
Email nabe-jun@comet.ocn.ne.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Miyamoto
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
Email 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
Email 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
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
2019 Year 11 Month 25 Day


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


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