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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name