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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028516
Receipt No. R000032431
Scientific Title Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method
Date of disclosure of the study information 2017/09/01
Last modified on 2019/08/07

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Basic information
Public title Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method
Acronym Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method
Scientific Title Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method
Scientific Title:Acronym Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of anastomotic blood flow using the ICG fluorescence method
Key secondary outcomes 1 Incidence rate of side effect
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 rectal 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 rectal 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 50

Research contact person
Name of lead principal investigator
1st name Masayoshi
Middle name
Last name Nakanishi
Organization Kyoto Prefectural University of Medicine
Division name Division of Digestive Surgery
Zip code 602-8566
Address 465 Kajii-cho, Kamigyo-ku, Kyoto city
TEL 075-251-5527
Email mnakan@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Masayoshi
Middle name
Last name Nakanishi
Organization Kyoto Prefectural University of Medicine
Division name Division of Digestive Surgery
Zip code 602-8566
Address 465 Kajii-cho, Kamigyo-ku, Kyoto city
TEL 075-251-5527
Homepage URL
Email mnakan@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural 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 Kyoto Prefectural University of Medicine
Address 465 Kajii-cho, Kamigyo-ku, Kyoto sity
Tel +81-75-251-5527
Email mnakan@koto.kpu-m.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

Other administrative information
Date of disclosure of the study information
2017 Year 09 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
2017 Year 11 Month 01 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 03 Day
Last modified on
2019 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032431

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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