UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046963 |
|---|---|
| Receipt number | R000053584 |
| Scientific Title | Study of discomfort in endoscopy |
| Date of disclosure of the study information | 2022/03/15 |
| Last modified on | 2024/08/26 09:24:07 |
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Basic information
Public title
Study of discomfort in endoscopy
Acronym
Study of discomfort in endoscopy
Scientific Title
Study of discomfort in endoscopy
Scientific Title:Acronym
Study of discomfort in endoscopy
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is important to reduce the discomfort in upper gastrointestinal endoscopy and colonoscopy. This study aims to clarify the factors related to discomfort.
Basic objectives2
Others
Basic objectives -Others
Clarify the following.
Association between lesion detection rate and examination time.
Association between endoscopist experience and discomfort.
Association between endoscopist experience and lesion detection rate.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Factors associated with increased discomfort in endoscopy.
Key secondary outcomes
Association between lesion detection rate and examination time.
Association between endoscopist experience and discomfort.
Association between endoscopist experience and lesion detection rate.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who underwent upper gastrointestinal endoscopy or colonoscopy at our Health Appraisal Center.
Key exclusion criteria
Participants who did not get consent.
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Majima |
Organization
Kameda Medical Center
Division name
Department of Health Management
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL
04-7092-2211
maji-ken@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Majima |
Organization
Kameda Medical Center
Division name
Department of Health Management
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL
04-7092-2211
Homepage URL
maji-ken@umin.ac.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
self funding.
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
Kameda General Hospital Clinical Research Review Committee Office
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
Tel
04-7092-2211
I can not publish it.
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
| 2022 | Year | 03 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For upper gastrointestinal endoscopy, the following information is collected: age, gender, current and past medical history, BMI, height, smoking history, drinking history, discomfort level in endoscopy, satisfaction level in endoscopy, history of endoscopy , endoscopic model , use of antispasmodics, biopsy done, use of Lugol's solution, presence of esophageal hiatal hernia , use of sedation, endoscopist information, and examination time. For colonoscopy, the following information was collected: current and past medical history, discomfort level in endoscopy, satisfaction level in endoscopy, age, gender, BMI, history of endoscopy , endoscope model , use of antispasmodics, use of sedation, insertion time, withdrawal time, endoscopist information, presence of diverticulum, and presence of polyps.
Management information
Registered date
| 2022 | Year | 02 | Month | 21 | Day |
Last modified on
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053584
