UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032356 |
|---|---|
| Receipt number | R000035699 |
| Scientific Title | The efficacy of prophylactic catheter insertion for outlet obstruction in patients with ulcerative colitis after surgery. |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2018/08/24 09:59:39 |
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Basic information
Public title
The efficacy of prophylactic catheter insertion for outlet obstruction in patients with ulcerative colitis after surgery.
Acronym
The efficacy of prophylactic catheter insertion for outlet obstruction in patients with ulcerative colitis after surgery.
Scientific Title
The efficacy of prophylactic catheter insertion for outlet obstruction in patients with ulcerative colitis after surgery.
Scientific Title:Acronym
The efficacy of prophylactic catheter insertion for outlet obstruction in patients with ulcerative colitis after surgery.
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of inserting prophylactic catheter from ileostomy for outlet obstruction in patients with ulcerative colitis after surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
incidence of the outlet obstruction during hospitalization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Inserting catheter from loop ileostomy
Natural extraction or 1 week
Interventions/Control_2
Without inserting catheter from loop ileostomy
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 loop ileostomy.
Patients with agreement.
Key exclusion criteria
Patients without agreement.
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruhiro Chohno |
Organization
Hyogo College of Medicine
Division name
Department of Inflammatory Bowel Disease
Zip code
Address
1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL
0798456371
chohnoo@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruhiro Chohno |
Organization
Hyogo College of Medicine
Division name
Department of Inflammatory Bowel Disease
Zip code
Address
1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL
0798456371
Homepage URL
chohnoo@hyo-med.ac.jp
Sponsor or person
Institute
Department of Inflammatory Bowel Disease
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Inflammatory Bowel Disease
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
| 2018 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | 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
| 2018 | Year | 04 | Month | 24 | Day |
Last modified on
| 2018 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035699
