UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019652 |
|---|---|
| Receipt number | R000022709 |
| Scientific Title | Analysis of the association between endoscopic finding of colonic diverticula and abdominal symptom |
| Date of disclosure of the study information | 2015/11/06 |
| Last modified on | 2017/03/21 21:33:35 |
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Basic information
Public title
Analysis of the association between endoscopic finding of colonic diverticula and abdominal symptom
Acronym
Colonic diverticula and abdominal symptom
Scientific Title
Analysis of the association between endoscopic finding of colonic diverticula and abdominal symptom
Scientific Title:Acronym
Colonic diverticula and abdominal symptom
Region
| Japan |
Condition
Condition
diverticular disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between endoscopic finding of colonic diverticula and abdominal symptom
Basic objectives2
Others
Basic objectives -Others
To evaluate the association between endoscopic finding of colonic diverticula and obesity
To evaluate the association between endoscopic finding of colonic diverticula and bowel habit
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between endoscopic finding of colonic diverticula and abdominal symptom
Key secondary outcomes
The association between endoscopic finding of colonic diverticula and obesity
The association between endoscopic finding of colonic diverticula and bowel habit
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Study subjects are consecutive Japanese
patients who undergo total colonoscopy at each center, and the
reason for colonoscopy is colon and rectal cancer screening
Key exclusion criteria
History of intestinal resection
Active intra-abdominal and pelvic malignancy
Inflammatory bowel disease
Microscopic colitis
Other organic gastrointestinal disorders that case abdominal symptoms
Pregnancy or possibility of pregnancy
Patients with dementia and psychiatric disorders
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Yamada |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Gastroenterology
Zip code
Address
3-2-10 Kounandai Kounan-ku, Yokohama City, Kanagawa, Japan
TEL
045-832-1111
yamadae@nanbu.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Yamada |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Gastroenterology
Zip code
Address
3-2-10 Kounandai Kounan-ku, Yokohama City, Kanagawa, Japan
TEL
045-832-1111
Homepage URL
yamadae@nanbu.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
n/a
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
diverticular disease study groups
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 | 11 | Month | 06 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 10 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Study Design case-control study
Evaluetion item
GSRS
Japanese Version of the Rome III Diagnostic Questionnaire for Irritable Bowel Syndrome
The Diverticular Inflammation and Complication Assessment (DICA)
score
Management information
Registered date
| 2015 | Year | 11 | Month | 05 | Day |
Last modified on
| 2017 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022709
