UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053842 |
|---|---|
| Receipt number | R000061452 |
| Scientific Title | Prospective sampling, multicenter registry study to investigate the prevalence and complications of Symptomatic uncomplicated diverticular disease (SUDD) in patients with diverticula |
| Date of disclosure of the study information | 2024/03/13 |
| Last modified on | 2024/03/13 06:45:53 |
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Basic information
Public title
Prospective sampling, multicenter registry study to investigate the prevalence and complications of Symptomatic uncomplicated diverticular disease (SUDD) in patients with diverticula
Acronym
Prospective sampling, multicenter registry study to investigate the prevalence and complications of Symptomatic uncomplicated diverticular disease (SUDD) in patients with diverticula
Scientific Title
Prospective sampling, multicenter registry study to investigate the prevalence and complications of Symptomatic uncomplicated diverticular disease (SUDD) in patients with diverticula
Scientific Title:Acronym
Prospective sampling, multicenter registry study to investigate the prevalence and complications of Symptomatic uncomplicated diverticular disease (SUDD) in patients with diverticula
Region
| Japan |
Condition
Condition
Patients with diverticula
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with diverticula, especially those with diverticulitis or diverticular hemorrhage, will be interviewed to determine if they have SUDD at the base. We will also observe and investigate subsequent complications and prognosis.
Basic objectives2
Others
Basic objectives -Others
Patients with diverticula, especially those with diverticulitis or diverticular hemorrhage, will be interviewed to determine if they have SUDD at the base. We will also observe and investigate subsequent complications and prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of SUDD
Key secondary outcomes
Prevalence of IBS
Percentage of SUDD and IBS Overlap
Duration of SUDD
Diet
Dietary preferences
Pain intensity and frequency
Comorbidity
Quality of life
Number of hospitalizations
Complications
Prognosis
Intestinal analysis in stool
Analysis of bile acid in blood
etc.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diverticula (especially those diagnosed with diverticula/diverticulitis/diverticular hemorrhage, etc.)
Key exclusion criteria
Patients who are unable to give consent to participate in the study or complete the questionnaires
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International university of health and welfare Narita hospital
Division name
Palliative medicine and Gastroenterology
Zip code
286-8520
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
0476355600
takaomi0027@gmail.com
Public contact
Name of contact person
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International university health and welfare Narita hospital
Division name
Palliative medicine and Gastroenterology
Zip code
286-8520
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
0476355600
Homepage URL
takaomi0027@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Self
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
International university health and welfare Narita hospital
Address
852, Hatakeda, Narita, Chiba
Tel
0476355600
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
大森赤十字病院、山王病院、国際医療福祉大学 三田病院、国際医療福祉大学熱海病院、横浜栄共済病院、横浜労災病院、神奈川歯科大学付属横浜クリニック、横須賀市立うわまち病院、さがみ林間病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 13 | 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
| 2023 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061452
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
