UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020196
Receipt number R000023323
Scientific Title Prospective study about treatment and QOL of large intestine malignancy stenosis
Date of disclosure of the study information 2015/12/21
Last modified on 2015/12/14 22:04:00

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Basic information

Public title

Prospective study about treatment and QOL of large intestine malignancy stenosis

Acronym

Prospective study about treatment and QOL of large intestine malignancy stenosis

Scientific Title

Prospective study about treatment and QOL of large intestine malignancy stenosis

Scientific Title:Acronym

Prospective study about treatment and QOL of large intestine malignancy stenosis

Region

Japan


Condition

Condition

large intestine malignancy stenosis

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Surgery in general
Obstetrics and Gynecology Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify of the highest quality of life treatment among large intestine stenting, anal ileus tube and colostomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of improvement of QOL using SF-36 healthy questionnaire

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

99 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Patients who are diagnosed large intestine malignancy stenosis
2.Patient who are treated with large intestine stent, an anus ileus tube or colostomy.

Key exclusion criteria

1.Patient who can not provide written agreement
2.Patient who can not answer the questionnaire because of low cognitive function

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Uchiyama Shiori

Organization

Yokohama City University school of medicine

Division name

Department of gastroenterology and hepatology

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Email

uchiyama-ykh@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Uchiyama Shiori

Organization

Yokohama City University school of medicine

Division name

Department of gastroenterology and hepatology

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Homepage URL


Email

uchiyama-ykh@umin.ac.jp


Sponsor or person

Institute

Yokohama CIty University School of Medicine Department of Gastroenterology and Hepatology

Institute

Department

Personal name



Funding Source

Organization

Yokohama CIty University School of Medicine Department of Gastroenterology and Hepatology

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


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

2015 Year 12 Month 21 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

2015 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 12 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

Observation period is one year


Management information

Registered date

2015 Year 12 Month 14 Day

Last modified on

2015 Year 12 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023323


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name