UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017540 |
|---|---|
| Receipt number | R000020324 |
| Scientific Title | Retrospective study for ostomy surgery in Japan |
| Date of disclosure of the study information | 2015/05/20 |
| Last modified on | 2015/05/13 12:22:56 |
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Basic information
Public title
Retrospective study for ostomy surgery in Japan
Acronym
Ostomy surgery in Japan
Scientific Title
Retrospective study for ostomy surgery in Japan
Scientific Title:Acronym
Ostomy surgery in Japan
Region
| Japan |
Condition
Condition
Patients after ostomy surgery
Classification by specialty
| Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate diameter of stoma after surgery in japan
Basic objectives2
Others
Basic objectives -Others
uniformity
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Uniformity of diameter of stoma
Key secondary outcomes
frequency of postperative complications
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
Ostomy surgery between Jan.2013 to Dec. 2014
Key exclusion criteria
jejunostomy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Itabashi |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery2
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku
TEL
03-3353-8111
itabashi@surg2.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Itabashi |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery2
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku
TEL
03-3353-8111
Homepage URL
itabashi@surg2.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Stoma and Continence Rehabilitation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京女子医科大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 20 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
evaliation of the diameter of stoma
Management information
Registered date
| 2015 | Year | 05 | Month | 13 | Day |
Last modified on
| 2015 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020324
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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