UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014716
Receipt number R000013782
Scientific Title Analysis and counterplan of the perioperative vital reaction related to gastroenterological surgery
Date of disclosure of the study information 2014/07/30
Last modified on 2014/07/30 20:15:32

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Basic information

Public title

Analysis and counterplan of the perioperative vital reaction related to gastroenterological surgery

Acronym

Analysis and counterplan of the perioperative vital reaction related to gastroenterological surgery

Scientific Title

Analysis and counterplan of the perioperative vital reaction related to gastroenterological surgery

Scientific Title:Acronym

Analysis and counterplan of the perioperative vital reaction related to gastroenterological surgery

Region

Japan


Condition

Condition

gastroenterological disease

Classification by specialty

Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Analysis of immune function related to gastroenterological surgery and a relationship between immune function and postoperative complications

Basic objectives2

Others

Basic objectives -Others

Analysis of immune function related to gastroenterological surgery and a relationship between immune function and postoperative complications

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the rate of postoperative complication

Key secondary outcomes



Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Elective surgery cases of gastroenterological disease

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

The patient who undergoes gastroenterological surgery

Key exclusion criteria

The patient without consent

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toru Kubo

Organization

National Defense Medical College

Division name

Department of Surgery

Zip code


Address

Namiki 3-2, Tokorozawa, Saitama 359-8513

TEL

+81-4-2995-1211

Email

drs1020@ndmc.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toru Kubo

Organization

National Defense Medical College

Division name

Department of Surgery

Zip code


Address

Namiki 3-2, Tokorozawa, Saitama 359-8513

TEL

+81-4-2995-1211

Homepage URL


Email

drs1020@ndmc.ac.jp


Sponsor or person

Institute

Department of Surgery, National Defense Medical College

Institute

Department

Personal name



Funding Source

Organization

National Defense Medical College

Organization

Division

Category of Funding Organization

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

2014 Year 07 Month 30 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

Open public recruiting

Date of protocol fixation

2012 Year 02 Month 07 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 07 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

2014 Year 07 Month 30 Day

Last modified on

2014 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013782


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name