UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031785 |
|---|---|
| Receipt number | R000036283 |
| Scientific Title | A questionnaire survey of constipation in patients undergoing palliative care |
| Date of disclosure of the study information | 2018/03/19 |
| Last modified on | 2021/09/20 11:49:56 |
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Basic information
Public title
A questionnaire survey of constipation in patients undergoing palliative care
Acronym
Constipation in palliative care
Scientific Title
A questionnaire survey of constipation in patients undergoing palliative care
Scientific Title:Acronym
Constipation in palliative care
Region
| Japan |
Condition
Condition
Patients receiving palliative care
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Gastrointestinal surgery | Adult | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to investigate the prevalence of constipation for patients undergoing palliative care and evaluate the causal relationship between constipation and quality of life
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Patient Assessment of Constipation Quality of Life
Key secondary outcomes
ROMA4, PAC-CSS, PAC-SYM, Short form(SF)36, Bristol scale
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing intervention by the Palliative Medical Department
Key exclusion criteria
Patients judged to be unable to take questionnaire survey
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
Yokohama city university hospotal
Division name
Palliative Medicine
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku
TEL
0457872640
takaomi0027@gmail.com
Public contact
Name of contact person
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
Yokohama city university hospotal
Division name
Palliative Medicine
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa
TEL
045-787-2640
Homepage URL
takaomi0027@gmail.com
Sponsor or person
Institute
Yokohama city university
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Yokohama city university hospotal
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa
Tel
045-787-2800
takaomi0027@gmail.com
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 | 03 | Month | 19 | 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
| 2017 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no
Management information
Registered date
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2021 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036283
