UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034598 |
|---|---|
| Receipt number | R000039445 |
| Scientific Title | Laser speckle contrast imaging for real-time visualization and quantitative assessment of intestinal blood perfusion during colorectal surgery |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2019/11/13 16:43:38 |
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Basic information
Public title
Laser speckle contrast imaging for real-time visualization and quantitative assessment of intestinal blood perfusion during colorectal surgery
Acronym
Laser speckle contrast imaging for assessment of intestinal blood perfusion during colorectal surgery
Scientific Title
Laser speckle contrast imaging for real-time visualization and quantitative assessment of intestinal blood perfusion during colorectal surgery
Scientific Title:Acronym
Laser speckle contrast imaging for assessment of intestinal blood perfusion during colorectal surgery
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of intraoperative bowel perfusion assessment with laser speckle contrast imaging during colorectal surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of intraoperative and postoperative complication
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) patients undergoing elective surgery for colorectal tumor
2) patients who understand purpose of study and receive informed consent[
3) patients with 20 years old or older
Key exclusion criteria
1) patients who are judged to be ineligible for subject by researcher
2) patients undergoing emergency surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shigehiro |
| Middle name | |
| Last name | Kojima |
Organization
Sainokuni Higashiomiya Medical Center
Division name
Department of Surgery
Zip code
331-8577
Address
1522 Toro-cho, Kita-ku, Saitama 331-8577, Japan
TEL
048-665-6111
shigehiro.kojima@shmc.jp
Public contact
Name of contact person
| 1st name | Shigehiro |
| Middle name | |
| Last name | Kojima |
Organization
Sainokuni Higashiomiya Medical Center
Division name
Department of Surgery
Zip code
331-8577
Address
1522 Toro-cho, Kita-ku, Saitama 331-8577, Japan
TEL
048-665-6111
Homepage URL
shigehiro.kojima@shmc.jp
Sponsor or person
Institute
Sainokuni Higashiomiya Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Joint Graduate School of Tokyo Women's University and Waseda University Cooperative Major in Advanced Biomedical Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sainokuni Higashiomiya Medical Center
Address
1522 Toro-cho, Kita-ku, Saitama 331-8577, Japan
Tel
048-665-6111
ekiko.sakuraba@shmc.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
| 2018 | Year | 11 | Month | 01 | 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
54
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
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Laser speckle perfusion images at the site of proximal transection of the bowel was obtained intraoperatively
Management information
Registered date
| 2018 | Year | 10 | Month | 22 | Day |
Last modified on
| 2019 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039445
