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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035450
Receipt No. R000040391
Official scientific title of the study Evaluation of bowel blood flow using intraoperative indocyanine green fluorescence imaging.
Date of disclosure of the study information 2019/01/05
Last modified on 2019/01/05

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Basic information
Official scientific title of the study Evaluation of bowel blood flow using intraoperative indocyanine green fluorescence imaging.
Title of the study (Brief title) Evaluation of bowel blood flow using intraoperative indocyanine green fluorescence imaging.
Region
Japan

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

Objectives
Narrative objectives1 We aim to identify whether ICG fluoresence imaging is useful for evaluation of intestinal blood flow for anastomosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes identification rate of intestinal blood flow around anastomosis with ICG fluoresence imaging
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
Medicine
Interventions/Control_1 ICG intravenous administration
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 Elective surgery for colorectal cancer
Key exclusion criteria Emergency surgery
Target sample size 50

Research contact person
Name of lead principal investigator Suguru Hasegawa
Organization Fukuoka University
Division name Department of Gastoroenterological Surgery
Address 7-45-1, Nanakuma Jonanku, Fukuoka, Japan
TEL 0928011011
Email ice13man1978@yahoo.co.jp

Public contact
Name of contact person Naoya Aisu
Organization Fukuoka University
Division name Department of Gastoroenterological Surgery
Address 7-45-1, Nanakuma Jonanku, Fukuoka, Japan
TEL 0928011011
Homepage URL
Email ice13man1978@yahoo.co.jp

Sponsor
Institute Fukuoka University
Institute
Department

Funding Source
Organization NA
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2019 Year 01 Month 05 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 07 Day
Anticipated trial start date
2017 Year 07 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 01 Month 05 Day
Last modified on
2019 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040391

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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