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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040958
Receipt No. 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 2020/06/30

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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
Email 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
Email tomoyukinagai@mac.com

Sponsor
Institute Kindai University
Institute
Department

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
Email 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
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 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
2020 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041277

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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