UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030045
Receipt number R000034307
Scientific Title Laser speckle contrast imaging for intraoperative semi-quantitative assessment of intestinal blood perfusion during colorectal surgery: a clinical pilot study
Date of disclosure of the study information 2017/12/25
Last modified on 2019/11/13 16:42:38

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Basic information

Public title

Laser speckle contrast imaging for intraoperative semi-quantitative assessment of intestinal blood perfusion during colorectal surgery: a clinical pilot study

Acronym

Laser speckle contrast imaging for intraoperative assessment of intestinal blood perfusion during colorectal surgery

Scientific Title

Laser speckle contrast imaging for intraoperative semi-quantitative assessment of intestinal blood perfusion during colorectal surgery: a clinical pilot study

Scientific Title:Acronym

Laser speckle contrast imaging for intraoperative 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 feasibility of intraoperative bowel perfusion assessments 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

Evaluation of blood perfusion of the anastomotic site

Key secondary outcomes

1) Reliability
2) Measuring time
3) Incidence rate of intraoperative and postoperative complication


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

Device,equipment

Interventions/Control_1

Assessment of bowel blood perfusion with laser speckle contrast imaging before anastomosis during colorectal resection

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 reveive informed consent
3) patents 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

10


Research contact person

Name of lead principal investigator

1st name Shgiehiro
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 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

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

彩の国東大宮メディカルセンター(埼玉県)


Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 25 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

8

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

2018 Year 03 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 20 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=R000034307


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name