UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023750 |
|---|---|
| Receipt number | R000023751 |
| Scientific Title | Association between outlet obstruction and ostomy site during restorative proctocolectomy in patients with ulcerative colitis. |
| Date of disclosure of the study information | 2016/08/24 |
| Last modified on | 2018/11/30 08:38:44 |
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Basic information
Public title
Association between outlet obstruction and ostomy site during restorative proctocolectomy in patients with ulcerative colitis.
Acronym
Association between outlet obstruction and ostomy site in UC surgery.
Scientific Title
Association between outlet obstruction and ostomy site during restorative proctocolectomy in patients with ulcerative colitis.
Scientific Title:Acronym
Association between outlet obstruction and ostomy site in UC surgery.
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between outlet obstruction and ostomy site during restorative proctocolectomy in patients with ulcerative colitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Prevalence of the outlet obstruction after ostomy creation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The ostomy create at the right lower quadrant abdominal wall.
Interventions/Control_2
The ostomy create at the left lower quadrant abdominal wall.
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patinets with ulcerative colitis who need proctocolectomy with ileal-pouch anal anastomosis and diverting ileostomy.
Key exclusion criteria
Patients without agreement.
Patients whose intestine will be expect to twist at already determined ostomy site.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Ikeuchi |
Organization
Hyogo College of Medicine
Division name
Dept of Inflammatory Bowel Disease
Zip code
Address
1-1 Mukogawacho, Nishinomiya, Hyogo
TEL
0798-45-6371
ikeuci2s@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoi Uchino |
Organization
Hyogo College o medicine
Division name
Dept of Inflammatory Bowel Disease
Zip code
Address
1-1 Mukogawacho, Nishinomiya, Hyogo
TEL
0798-45-6371
Homepage URL
motoi.uchino@nifty.ne.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College 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
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
| 2016 | Year | 08 | Month | 24 | 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
| 2016 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before study
Management information
Registered date
| 2016 | Year | 08 | Month | 24 | Day |
Last modified on
| 2018 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023751
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| Registered date | File name |
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| Registered date | File name |
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