UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051752 |
|---|---|
| Receipt number | R000058820 |
| Scientific Title | A multicenter prospective observational study investigating blood flow evaluation using indocyanine green fluorescence method during surgery for strangulated small bowel obstruction |
| Date of disclosure of the study information | 2023/09/30 |
| Last modified on | 2023/07/30 10:25:41 |
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Basic information
Public title
A multicenter prospective observational study investigating blood flow evaluation using indocyanine green fluorescence method during surgery for strangulated small bowel obstruction
Acronym
iFEISS study (JSFGS-1)
Scientific Title
A multicenter prospective observational study investigating blood flow evaluation using indocyanine green fluorescence method during surgery for strangulated small bowel obstruction
Scientific Title:Acronym
iFEISS study (JSFGS-1)
Region
| Japan |
Condition
Condition
Strangulated small bowel obstruction
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the frequency of changes in surgical plans, which include intestinal preservation or resection or resection with jejunostomy, ileostomy or colostomy, based on intestinal viability evaluation in strangulated intestinal obstruction by blood flow evaluation using Indocyanine Green (ICG) fluorescence method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Primary endpoint
The frequency of changes in surgical plans, which include intestinal preservation or resection or resection with jejunostomy, ileostomy or colostomy.
2) Secondary endpoint
Clinical finding of ICG fluorescence method
The frequency of changes in surgical plans using ICG fluorescence method in each surgeon
The change of resected intestinal length using ICG fluorescence method
Pathological findings of resected intestine
Morbidity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Diagnosis of strangulated intestinal obstruction by computed tomography
2) Possible of intraoperative diagnosis using near infrared light
3) Twenty years of age or older
4) Written consent is obtained
Key exclusion criteria
1) Shock status required circulatory agonist before surgery
2) Suspicion of intestinal necrosis before surgery
3) Iodine allergy
4) Severe ischemic heart disease
5) Liver cirrhosis of active hepatitis
6) Dyspnea required oxygen therapy
7) Hemodialysis due to chronic renal failure
8) Pregnant or lactating woman
9) Other cases including judged by the attending physician to be unsuitable
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Namikawa |
Organization
Kochi Medical School
Division name
Department of Surgery,
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL
088-880-2370
tsutomun@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kitagawa |
Organization
Kochi Medical School
Division name
Department of Surgery,
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL
088-880-2370
Homepage URL
kitagawah@kochi-u.ac.jp
Sponsor or person
Institute
Japanese Society for Fluorescence Guided Surgery
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Fluorescence Guided Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
Tel
088-880-2370
im31@kochi-u.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
| 2023 | Year | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2023 | Year | 07 | Month | 30 | Day |
Last modified on
| 2023 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058820
