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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031755
Receipt No. R000035802
Scientific Title Prospective Study of Laparoscopic Navigation Surgery with using Indocyanine green-labelled Omental Appendices
Date of disclosure of the study information 2018/03/20
Last modified on 2018/03/15

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Basic information
Public title Prospective Study of Laparoscopic Navigation Surgery with using Indocyanine green-labelled Omental Appendices
Acronym ICG-OA navigation surgery
Scientific Title Prospective Study of Laparoscopic Navigation Surgery with using Indocyanine green-labelled Omental Appendices
Scientific Title:Acronym ICG-OA navigation surgery
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of laparoscopic navigation surgery with using indocyanine green-labelled omental appendices
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate of indocyanine green-labelled omental appendices
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 ICG-labelled omental appendices
Interventions/Control_2
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 Histologically proven colorectal cancer.
Stage 0-III.
Patients without iodine hypersensitivity.
age >= 20
Performance status 0-2
Without other primary cancer arising from organs other than colon and rectum
Without iodine hypersensitivity.
Provided written informed consent
Key exclusion criteria Patients with other primary cancer arising from organs other than colon and rectum.
Severe mental disease
Not appropriate for the study at the physician's assessment
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Hamabe
Organization Toyonaka Municipal Hospital
Division name Department of Surgerye
Zip code
Address 4-14-1 Shibahara-cho, Toyonaka, Osaka, Japan
TEL 06-6843-0101
Email ahamabe1981@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Hamabe
Organization Toyonaka Municipal Hospital
Division name Department of Surgery
Zip code
Address 4-14-1 Shibahara-cho, Toyonaka, Osaka, Japan
TEL 06-6843-0101
Homepage URL
Email ahamabe1981@gmail.com

Sponsor
Institute Toyonaka Municipal Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 20 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 15 Day
Last modified on
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035802

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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