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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022876
Receipt No. R000026365
Scientific Title Evaluation of anastomotic blood flow in colorectal surgery using the ICG fluorescence method
Date of disclosure of the study information 2016/07/15
Last modified on 2019/02/06

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Basic information
Public title Evaluation of anastomotic blood flow in colorectal surgery using the ICG fluorescence method
Acronym Evaluation of anastomotic blood flow in colorectal surgery using the ICG fluorescence method
Scientific Title Evaluation of anastomotic blood flow in colorectal surgery using the ICG fluorescence method
Scientific Title:Acronym Evaluation of anastomotic blood flow in colorectal surgery using the ICG fluorescence method
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of anastomotic blood flow in colorectal surgery using the ICG fluorescence method
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Possibility of prediction by evaluation of anastomotic blood flow using the ICG fluorescence method
Key secondary outcomes 1 Evaluation of anastomotic blood flow
2 Incidence rate of anastomotic leakage

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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Indocyanine green injection at the colorectal surgery
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 1 Scheduled for elective surgery for a colorectal cancer
2 Age>=20
3 Written informed consent
Key exclusion criteria 1 Allergic hypersensitivity of the indocyanine green
2 Allergic hypersensitivity of the iodine
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Matsuda
Organization Wakayama Medical University of Medicine
Division name The Second department of Surgery
Zip code
Address 811-1, Kimiidera, Wakayama, Wakayama 641-8510
TEL 074-441-0613
Email kmatsuda@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromitsu Iwamoto
Organization Wakayama Medical University of Medicine
Division name The Second department of Surgery
Zip code
Address 811-1, Kimiidera, Wakayama, Wakayama 641-8510
TEL 074-441-0613
Homepage URL
Email hiwa@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University of Medicine
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
2016 Year 07 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2016 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 15 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
2019 Year 01 Month 31 Day
Date trial data considered complete
2019 Year 01 Month 31 Day
Date analysis concluded
2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 24 Day
Last modified on
2019 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026365

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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