UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032228
Receipt number R000036750
Scientific Title Investigation for the mechanism of bacterial translocation in patients undergoing surgery of intestinal necrosis. A multiple institutional prospective study.
Date of disclosure of the study information 2018/10/01
Last modified on 2018/04/13 11:54:18

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Basic information

Public title

Investigation for the mechanism of bacterial translocation in patients undergoing surgery of intestinal necrosis. A multiple institutional prospective study.

Acronym

Investigation for the mechanism of bacterial translocation in patients undergoing surgery of intestinal necrosis.

Scientific Title

Investigation for the mechanism of bacterial translocation in patients undergoing surgery of intestinal necrosis. A multiple institutional prospective study.

Scientific Title:Acronym

Investigation for the mechanism of bacterial translocation in patients undergoing surgery of intestinal necrosis.

Region

Japan


Condition

Condition

Patients who are going to undergo open abdominal surgery for intestinal necrosis.

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the mechanism of bacterial translocation using samples from patients undergoing surgery for intestinal necrosis.

Basic objectives2

Others

Basic objectives -Others

To investigate the pattern of bacterial translocation in necrotic intestine.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clarify the mechanism of bacterial translocation in human by examining blood, feces, resected intestinal specimen, and mesenteric lymph nodes.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Use the specimens from patients undergoing a surgery for intestinal necrosis. Analyze the resected specimen, mesenteric lymph nodes, blood, and fecal samples.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All patients undergoing surgery for intestinal necrosis.

Key exclusion criteria

Not applicable.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukihiro Yokoyama

Organization

Nagoya University Graduate School of Medicine

Division name

Division of Surgical Oncology, Department of Surgery

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan

TEL

052-744-2218

Email

yyoko@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukihiro Yokoyama

Organization

Nagoya University Graduate School of Medicine

Division name

Division of Surgical Oncology, Department of Surgery

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan

TEL

052-744-2218

Homepage URL


Email

yyoko@med.nagoya-u.ac.jp


Sponsor or person

Institute

Division of Surgical Oncology, Department of Surgery
Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Surgical Oncology, Department of Surgery
Nagoya University Graduate School of Medicine

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


Address


Tel


Email



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 10 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

Preinitiation

Date of protocol fixation

2018 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 13 Day

Last modified on

2018 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036750


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name