UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022876 |
|---|---|
| Receipt number | 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 21:18:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hiwa@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026365
