UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056639 |
|---|---|
| Receipt number | R000064738 |
| Scientific Title | Survey of Pain and Incidentalities Associated with Upper Gastrointestinal Endoscopy |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/07/08 15:41:01 |
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Basic information
Public title
Survey of Pain and Incidentalities Associated with Upper Gastrointestinal Endoscopy
Acronym
Survey of Pain and Incidentalities Associated with Upper Gastrointestinal Endoscopy
Scientific Title
Survey of Pain and Incidentalities Associated with Upper Gastrointestinal Endoscopy
Scientific Title:Acronym
Survey of Pain and Incidentalities Associated with Upper Gastrointestinal Endoscopy
Region
| Japan |
Condition
Condition
Upper Gastrointestinal Endoscopy
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In narrow upper gastrointestinal endoscopy, the endoscope is inserted through the nose or mouth to observe the esophagus, stomach, and duodenum after administering drugs (antifoaming agents and mucus removers) and local infiltration anesthesia with lidocaine immediately before the examination. Biopsies using forceps are added as appropriate. Surveys conducted by the Japanese Society of Gastrointestinal Endoscopy have identified the occurrence of relatively serious accidents due to drugs, anesthetics, and endoscopic manipulation during the examination, but no reports of minor distress. In addition, we have not been able to ascertain the occurrence and severity of symptoms of contingencies that occur after the patient returns home. The purpose of this study was to investigate the occurrence and severity of symptoms before and after the examination, as well as one week after the examination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A questionnaire survey (an observational study) will be conducted for the purpose of investigating the incidentalities associated with narrow upper gastrointestinal endoscopy. The principal investigator will explain the study to all consecutive patients who have undergone the examination, and will give the questionnaire to those who have confirmed their willingness to participate in the study. The research subjects will describe and submit a description of the degree of pain before and after the examination immediately after the examination. The research subjects will be observed for symptoms for up to one week thereafter, and if there is a contingency event, they will self-administer the symptoms, their degree and duration of occurrence on the questionnaire, and return it to the research office by mail.
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
Those who have undergone a narrow upper gastrointestinal endoscopy at Harusaki Health Screening Center as part of a physical checkup or gastric cancer screening
Key exclusion criteria
Persons who cannot give consent to participate in research
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | TSUNEYA |
| Middle name | |
| Last name | WADA |
Organization
Okazaki City Medical Association
Division name
Harusaki Medical check Center
Zip code
4440875
Address
1-9-1 Tatsumi-nishi Okazaki Aichi JAPAN
TEL
+81-564-52-1572
wadat0123@yahoo.co.jp
Public contact
Name of contact person
| 1st name | TSUNEYA |
| Middle name | |
| Last name | WADA |
Organization
Okazaki City Medical Association
Division name
Harusaki Medical check Center
Zip code
4440875
Address
1-9-1 Tatsumi-nishi Okazaki Aichi JAPAN
TEL
+81-564-52-1572
Homepage URL
wadat0123@yahoo.co.jp
Sponsor or person
Institute
Okazaki City Medical Association
Institute
Department
Personal name
Funding Source
Organization
None
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
Nagoya City University
Address
Kawasumi Mizuho Nagoya Aichi JAPAN
Tel
+81-52-851-5511
wadat0123@yahoo.co.jp
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
| 2025 | Year | 01 | 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
| 2024 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 01 | Month | 06 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064738
