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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040306
Receipt No. R000045986
Scientific Title Actual state of constipation and its factors in patients with chronic respiratory failure
Date of disclosure of the study information 2020/05/04
Last modified on 2020/11/04

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Basic information
Public title Actual state of constipation and its factors in patients with chronic respiratory failure
Acronym Chronic respiratory failure and constipation
Scientific Title Actual state of constipation and its factors in patients with chronic respiratory failure
Scientific Title:Acronym Chronic respiratory failure and constipation
Region
Japan

Condition
Condition Chronic respitory failure
Classification by specialty
Medicine in general Pneumology Geriatrics
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the frequency and severity of constipation in patients with chronic respiratory failure, and the relationship between activity and respiratory status and constipation.
Basic objectives2 Others
Basic objectives -Others It may be possible to clarify the need for interventions such as defecation control by investigating the occurrence of constipation and subjective symptoms associated with constipation.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Current bowel pattern and properties (Bristol scale)
Severity of constipation (Constipation Scoring System)
Effect of constipation on quality of life (JPAC-QOL)
The time when became aware of constipation
Key secondary outcomes Existence of shortness of breath during excretion
Difficulty breathing, comfort, and security when bowel movements are good or bad (constipation) (Borg scale and VAS)
Health-related quality of life (SRI) for patients with chronic respiratory failure
Current activity
Anxiety and depression assessment (HAD)
Questionnaires such as sleep quality (PSQI) Basic diseases, age, sex, height, weight, oxygen flow rate, presence or absence of NPPV use, spirometry, 6-minute walking test, various blood test data including blood gas, constipation medication Frequency and type of medication, dosage details other than constipation medication

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with chronic respiratory failure. Underling disease do not matter (COPD, Interstitial pneumoniae, Nontuberculous mycobacteriosis, Bronchiectasis, etc.)
Previous treatment do not matter.
There is no limitation with laboratory data.
Key exclusion criteria Clinically Unstable
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Hisae
Middle name
Last name Sano
Organization National Hospital Organization Minami Kyoto Hospital
Division name Nursing department
Zip code 610-0113
Address Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL 0774-52-0065
Email kensukesumi@gmail.com

Public contact
Name of contact person
1st name Kensuke
Middle name
Last name Sumi
Organization National Hospital Organization Minami Kyoto Hospital
Division name Department of Respiratory Medicine
Zip code 610-0113
Address Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL 0774-52-0065
Homepage URL
Email kensukesumi@gmail.com

Sponsor
Institute Department of Respiratory Medicine, National Hospital Organization Minami-Kyoto Hospital
Institute
Department

Funding Source
Organization Department of Respiratory Medicine, National Hospital Organization Minami-Kyoto Hospital
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 National Hospital Organization Minami Kyoto Hospital
Address Naka Ashihara 11, Joyo city, Kyoto, Japan
Tel 0774-52-0065
Email kensukesumi@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
2020 Year 05 Month 04 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 No longer recruiting
Date of protocol fixation
2020 Year 04 Month 27 Day
Date of IRB
2020 Year 04 Month 27 Day
Anticipated trial start date
2020 Year 04 Month 27 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Conduct a simple questionnaire survey that is an extension of daily clinical practice.
Collect patient information from electronic medical records.

Management information
Registered date
2020 Year 05 Month 04 Day
Last modified on
2020 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045986

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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