UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041277