UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049376 |
|---|---|
| Receipt number | R000056230 |
| Scientific Title | Pathophysiology of chronic constipation of anorectal outlet obstruction using rapid barostat bag test, anorectal manometry and rectal mucosa biopsy samples. |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2023/08/30 14:07:46 |
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Basic information
Public title
Pathophysiology of chronic constipation of anorectal outlet obstruction using rapid barostat bag test, anorectal manometry and rectal mucosa biopsy samples.
Acronym
Pathophysiology of chronic constipation of anorectal outlet obstruction.
Scientific Title
Pathophysiology of chronic constipation of anorectal outlet obstruction using rapid barostat bag test, anorectal manometry and rectal mucosa biopsy samples.
Scientific Title:Acronym
Pathophysiology of chronic constipation of anorectal outlet obstruction.
Region
| Japan |
Condition
Condition
chronic constipation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the pathogenesis of chronic constipation of anorectal outlet obstruction by evaluating rectoanal function in patients with chronic constipation using a combination of rapid barostat bag test, anorectal manometry and analysis of biopsy samples.
Basic objectives2
Others
Basic objectives -Others
To clarify the pathogenesis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between severity of functional constipation and intestinal perception and anal sphincter function.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients with chronic constipation who have been diagnosed with functional constipation by lower gastrointestinal endoscopy and biopsy tissue diagnosis, as organic constipation is considered necessary to exclude.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic constipation by March 31, 2027 who have been diagnosed with functional constipation by lower gastrointestinal endoscopy and biopsy tissue diagnosis, as organic constipation is considered necessary to exclude.
Key exclusion criteria
(1) Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, hemorrhage, and anemia), or rapid weight loss
(2) Patients with other factors (comorbidities or history of surgery) that may affect the results of rapid barostat bag test or anorectal manometry
(3) Patients with serious organ damage or concomitant psychiatric disorders
(4) Patients with confirmed or suspected malignant lesions
(5) Pregnant women, lactating women, or women who may be pregnant
(6) Other patients deemed inappropriate for this study by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Tanaka |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL
+81-92-642-5286
tanaka.yoshimasa.997@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Tanaka |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL
+81-92-642-5286
Homepage URL
tanaka.yoshimasa.997@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
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
Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
Tel
+81-92-642-5286
tanaka.yoshimasa.997@m.kyushu-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
| 2022 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056230
