UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029870 |
|---|---|
| Receipt number | R000034117 |
| Scientific Title | Evaluation of the intestinal blood flow using Indocyanine green(ICG)fluorescence method in abdominal emergency surgery |
| Date of disclosure of the study information | 2017/11/08 |
| Last modified on | 2022/11/12 17:45:28 |
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Basic information
Public title
Evaluation of the intestinal blood flow using Indocyanine green(ICG)fluorescence method in abdominal emergency surgery
Acronym
Evaluation of the intestinal blood flow using Indocyanine green(ICG)fluorescence method in abdominal emergency surgery
Scientific Title
Evaluation of the intestinal blood flow using Indocyanine green(ICG)fluorescence method in abdominal emergency surgery
Scientific Title:Acronym
Evaluation of the intestinal blood flow using Indocyanine green(ICG)fluorescence method in abdominal emergency surgery
Region
| Japan |
Condition
Condition
Acute abdomen
Classification by specialty
| Gastroenterology | Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the blood flow in intestinal tract with ischemia using the ICG fluorescence method in abdominal emergency surgery
Basic objectives2
Others
Basic objectives -Others
Presence of postoperative morbidity
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of ICG fluorescence in intestinal tract with ischemia
Key secondary outcomes
1 Presence of intestinal necrosis
2 Postoperative morbidity
3 Postoperative hospital stay
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 intravenous injection at the abdominal emergency 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 Abdominal emergency surgery patient
2 Written informed consent
Key exclusion criteria
1 Allergic hypersensitivity of the indocyanine green
2 Cases of incapacity decided by attending physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ueda |
Organization
Minami-Nara General Medical Center
Division name
Department of Surgery
Zip code
6388551
Address
8-1 Fukugami, Oyodo, Yoshino, Nara, Japan
TEL
0747-54-5000
takeueda@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ueda |
Organization
Minami-Nara General Medical Center
Division name
Department of Surgery
Zip code
6388551
Address
8-1 Fukugami, Oyodo, Yoshino, Nara, Japan
TEL
0747-54-5000
Homepage URL
takeueda@naramed-u.ac.jp
Sponsor or person
Institute
Minami-Nara General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Minami-Nara General Medical Center
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
Minami-Nara General Medical Center
Address
8-1 Fukugami, Oyodo, Yoshino, Nara, Japan
Tel
0747-54-5000
takeshiueda8@yahoo.co.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
南奈良総合医療センター(奈良県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 08 | 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
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It is taking a long time to write results.
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2022 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2022 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034117
