UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049857 |
|---|---|
| Receipt number | R000056354 |
| Scientific Title | A study on the relationship between esophageal achalasia and chronic constipation: a prospective study |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/12/21 16:30:09 |
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Basic information
Public title
A study on the relationship between esophageal achalasia and chronic constipation: a prospective study
Acronym
A study on the relationship between esophageal achalasia and chronic constipation: a prospective study
Scientific Title
A study on the relationship between esophageal achalasia and chronic constipation: a prospective study
Scientific Title:Acronym
A study on the relationship between esophageal achalasia and chronic constipation: a prospective study
Region
| Japan |
Condition
Condition
esophageal achalasia and chronic constipation
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the frequency of chronic constipation, defecation situation characteristics, and constipation-related QOL in patients with esophageal achalasia.
Basic objectives2
Others
Basic objectives -Others
Epidemiological investigation
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of chronic constipation in patients with esophageal achalasia.
Key secondary outcomes
1. Investigation of factors affecting JPAC-QOL (score).
2. Investigation of factors that affect defecation status (Bristol stool shape score, number of defecations).
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 with esophageal achalasia
Key exclusion criteria
1. Patients who have undergone abdominal surgery except for appendicitis.
2. Patients with intestinal diseases such as inflammatory bowel disease, ulcerative colitis, and Crohn's disease.
3. Patients who have been diagnosed with gastrointestinal cancers.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naotaka |
| Middle name | |
| Last name | Ogasawara |
Organization
Aichi Medical University School of Medicine
Division name
Gastroenterology
Zip code
480-1195
Address
1-1, Yazakokarimata, Nagakute, Aichi
TEL
0561623311
nogasa@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Naotaka |
| Middle name | |
| Last name | Ogasawara |
Organization
Aichi Medical University School of Medicine
Division name
Gastroenterology
Zip code
480-1195
Address
1-1, Yazakokarimata, Nagakute, Aichi
TEL
0561623311
Homepage URL
nogasa@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University School of Medicine
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
Aichi Medical University School of Medicine
Address
1-1, Yazakokarimata, Nagakute, Aichi
Tel
0561623311
kenshi@aichi-med-u.ac.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
| 2023 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2027 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
None.
Management information
Registered date
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056354
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
