UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039166 |
|---|---|
| Receipt number | R000044669 |
| Scientific Title | The impact of chronic constipation on quality of life of hemodialysis patients : a retrospective study |
| Date of disclosure of the study information | 2020/01/16 |
| Last modified on | 2023/07/25 12:12:08 |
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Basic information
Public title
The impact of chronic constipation on quality of life of hemodialysis patients : a retrospective study
Acronym
The impact of chronic constipation on quality of life of hemodialysis patients : a retrospective study
Scientific Title
The impact of chronic constipation on quality of life of hemodialysis patients : a retrospective study
Scientific Title:Acronym
The impact of chronic constipation on quality of life of hemodialysis patients : a retrospective study
Region
| Japan |
Condition
Condition
Chronic constipation, Chronic renal disease
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the impact of chronic constipation on quality of life of hemodialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcome is the effect of constipation on Japanese version Patient Assessment of Constipation of Quality of Life (JPAC-QOL) scale
Key secondary outcomes
Secondary outcomes included 1) the effect of constipation on Bristol Stool Form Score and frequency spontaneous bowel movements, 2) evaluation of end stage renal disease specific factors in the JPAC-QOL, 3) the association between the Bristol Stool Form Score and frequency spontaneous bowel movements to JPAC-QOL score, and 4) agreement of constipation score and Rome IV criteria
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are treated with maintenance hemodialysis for one month or more
Patients with 20 years old or older
Patients with chronic constipation who are treated with anti-constipation agents or not.
Key exclusion criteria
Patients who had or suspected ileus due to tumor or hernia
Patients who had constipation due to structural disorder
Patients who attending physicians consider being inappropriate due to other reasons mentioned above
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Murasawa |
Organization
Oyokyo Kidney Research Institute Hirosaki Hospital
Division name
Urology
Zip code
0368243
Address
90 yamazaki, kozawa, Hirosaki, Japan
TEL
0172871221
murasawa.hirom@gmail.com
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Murasawa |
Organization
Oyokyo Kidney Research Institute Hirosaki Hospital
Division name
Urology
Zip code
0368243
Address
90 yamazaki, kozawa, Hirosaki, Japan
TEL
0172871221
Homepage URL
murasawa.hirom@gmail.com
Sponsor or person
Institute
Oyokyo Kidney Research Institute Hirosaki Hospital
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Graduate School of medicine Institutional Review Board
Address
5 zaifu-chou, Hirosaki, Japan
Tel
0172395194
jm5194@cc.hirosaki-u.ac.jp
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 | 01 | Month | 16 | 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
121
Results
The frequency of weekly spontaneous bowel movement (2 per week or less) significantly associated with JPAC-QOL total scale score.
Results date posted
| 2022 | Year | 07 | Month | 20 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to analysis in progress
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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruiting: patients who visit the hospital between January 2020 and March 2021 and fulfill the inclusion criteria
Management information
Registered date
| 2020 | Year | 01 | Month | 15 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044669
