UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012334 |
|---|---|
| Receipt number | R000014356 |
| Scientific Title | Clinical trial of ostomy creation with tissue adhesives. |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2016/09/01 11:58:51 |
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Basic information
Public title
Clinical trial of ostomy creation with tissue adhesives.
Acronym
Ostomy creation with tissue adhesives.
Scientific Title
Clinical trial of ostomy creation with tissue adhesives.
Scientific Title:Acronym
Ostomy creation with tissue adhesives.
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safty of ostomy creation with tissue adhesives in phase 1 trial.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Early complications in ostomy creation which include wound dehiscence and collapse
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
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Tissue adhesives
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 inflammatory bowel disease who need ostomy creation in surgical procedure.
Key exclusion criteria
Obesity (Body mass indexs are higher than 25.
Emergent surgery.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoi Uchino |
Organization
Hyogo college of medicine
Division name
Lower gastroenterological surgery
Zip code
Address
1-1, Mukogawacho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6371
motoi.uchino@nifty.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoi Uchino |
Organization
Hyogo college of medicine
Division name
Lower gastroenterological surgery
Zip code
Address
1-1, Mukogawacho, Nishinomiya, Hyogo, Japan
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
| 2013 | Year | 12 | 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
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 18 | Day |
Last modified on
| 2016 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014356
