UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040958 |
|---|---|
| Receipt number | R000041277 |
| Scientific Title | Questionnaire survey for improvement of patient satisfaction in colonoscopy |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2021/07/01 10:00:55 |
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Basic information
Public title
Questionnaire survey for improvement of patient satisfaction in colonoscopy
Acronym
Questionnaire survey after colonoscopy
Scientific Title
Questionnaire survey for improvement of patient satisfaction in colonoscopy
Scientific Title:Acronym
Questionnaire survey after colonoscopy
Region
| Japan |
Condition
Condition
Colon cancer colon polyp inflammatory bowel disease
fecal occult blood positive Bloody stool Irritable bowel syndrome
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients sometimes complain of pain or discomfort with colonoscopy, and we will conduct this study to find out more about the factors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
What are the factors of patient satisfaction after colonoscopy and treatment?
before and after lower endoscopy.
Key secondary outcomes
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 can receive colonoscopy and treatment
Patients who do not meet exclusion criteria
Key exclusion criteria
Patients who do not agree with this study
Patients who can not answer questionnaires due to decline in cognitive function
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Nagai |
Organization
Kindai University
Division name
gastroenterology and Hepatology
Zip code
589-8511
Address
377-2, Onohigashi, Osakasayama Shi, Osaka Fu
TEL
072-366-0221
tomoyukinagai@mac.com
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Nagai |
Organization
Kindai University
Division name
gastroenterology and Hepatology
Zip code
589-8511
Address
377-2, Onohigashi, Osakasayama Shi, Osaka Fu
TEL
072-366-0221
Homepage URL
tomoyukinagai@mac.com
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
none
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
Kindai University
Address
377-2, Onohigashi, Osakasayama Shi, Osaka Fu
Tel
072-366-0221
tomoyukinagai@mac.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
近畿大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 01 | 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
| Delay expected |
Results Delay Reason
We refrained from lower endoscopy and its data registration in Corona Situation.
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
We survey the patient before and after lower endoscopy.
And we evaluate the lower endoscopy based on the result.
Management information
Registered date
| 2020 | Year | 06 | Month | 30 | Day |
Last modified on
| 2021 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041277
