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
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
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
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
