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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034598
Receipt No. 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 2019/04/13

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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
Email 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
Email shigehiro.kojima@shmc.jp

Sponsor
Institute Sainokuni Higashiomiya Medical Center
Institute
Department

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
Email 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 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 No longer recruiting
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 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039445

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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