UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028033 |
|---|---|
| Receipt number | R000032099 |
| Scientific Title | Incidence and risk factor of outlet obstruction after construction of ileostomy |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2017/07/01 17:42:06 |
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Basic information
Public title
Incidence and risk factor of outlet obstruction after construction of ileostomy
Acronym
Risk factor of outlet obstruction
Scientific Title
Incidence and risk factor of outlet obstruction after construction of ileostomy
Scientific Title:Acronym
Risk factor of outlet obstruction
Region
| Japan |
Condition
Condition
Ulcerative colitis, Familiar adenomatous polyposis, rectal cancer, etc
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the frequency and risk factors of outlet obstruction after construction of ileostomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors of outlet obstruction after construction of ileostomy.
Key secondary outcomes
Incidence of outlet obstruction after construction of ileostomy.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients those who were constructed ileostomy at Chiba university Hospital between January 2010 to December 2015.
2) Presence of detailed surgical record
Key exclusion criteria
1) Patients who died within 30 days after surgery
2) Patients who died without being able to ingest orally even at once after surgery
Target sample size
107
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisahiro Matsubara |
Organization
Graduate school of medicine, Chiba University
Division name
Department of frontier surgery
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken
TEL
043-226-2110
matsuhm@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Gaku ohira |
Organization
Graduate school of medicine, Chiba University
Division name
Department of frontier surgery
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken
TEL
043-226-2110
Homepage URL
Ohira@faculty.chiba-u.jp
Sponsor or person
Institute
Graduate school of medicine, Chiba University
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We accumulated data of 107 cases as planned.
Management information
Registered date
| 2017 | Year | 07 | Month | 01 | Day |
Last modified on
| 2017 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032099
