UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028267 |
|---|---|
| Receipt number | R000032354 |
| Scientific Title | Evaluation of anorectal functions using high-definition anorectal manometry in patients with anal diseases or after colorectal surgery |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/07/21 07:58:35 |
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Basic information
Public title
Evaluation of anorectal functions using high-definition anorectal manometry in patients with anal diseases or after colorectal surgery
Acronym
Evaluation of anorectal functions using high-definition anorectal manometry in patients with anal diseases or after colorectal surgery
Scientific Title
Evaluation of anorectal functions using high-definition anorectal manometry in patients with anal diseases or after colorectal surgery
Scientific Title:Acronym
Evaluation of anorectal functions using high-definition anorectal manometry in patients with anal diseases or after colorectal surgery
Region
| Japan |
Condition
Condition
patients with anal diseases, anorectal dysfunction or after colorectal surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the change in defecation function after surgery, the process of recovery of defecation dysfunction, and the comparison of defecation function with anastomotic sites using high definition anorectal manometory (HD-ARM)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
anorectal pressures in rest, squeeze, and bear down
Key secondary outcomes
presence of rectoanal inhibitory reflex
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 anal diseases, anorectal dysfunction or after colorectal surgery
Key exclusion criteria
patients who had surgical complication such as anastomotic leakage or anastomotic stricture
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Eto |
Organization
The Jikei University School of Medicine
Division name
Department of Surgery
Zip code
105-8461
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
kyanaga@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Eto |
Organization
The Jikei University School of Medicine
Division name
Department of Surgery
Zip code
105-8461
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
etoken@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
The Ethical Committee of the Jikei University School of Medicine.
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.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
| 2017 | Year | 08 | 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
| 2017 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of anorectal functions using high-definition anorectal manometry
Management information
Registered date
| 2017 | Year | 07 | Month | 18 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032354
