UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004890 |
|---|---|
| Receipt number | R000005824 |
| Scientific Title | Capsule endoscopy for the assessment of remaining small bowel lesions at surgery and postsurgical recurrence in patients with Crohn's disease |
| Date of disclosure of the study information | 2011/01/17 |
| Last modified on | 2019/01/23 14:04:34 |
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Basic information
Public title
Capsule endoscopy for the assessment of remaining small bowel lesions at surgery and postsurgical recurrence in patients with Crohn's disease
Acronym
Capsule endoscopy for the assessment of postsurgical lesions of Crohn's disease
Scientific Title
Capsule endoscopy for the assessment of remaining small bowel lesions at surgery and postsurgical recurrence in patients with Crohn's disease
Scientific Title:Acronym
Capsule endoscopy for the assessment of postsurgical lesions of Crohn's disease
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the remaining small bowel lesions at the early postoperative period of Crohn's disease using capsule endoscopy. In addition, the diagnostic advantage of chromo-capsule endoscopy is also investigated by a randomized crossover study.
Basic objectives2
Others
Basic objectives -Others
To investigate the postsurgical recurrence, patients are reexamined at 6 months after surgery by capsule endoscopy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.The degree of remaining small bowel lesions at the early postoperative period of Crohn's disease using capsule endoscopy
2.The degree of postsurgical recurrence at 6 months after surgery of Crohn's disease using capsule endoscopy
Key secondary outcomes
The diagnostic advantage of chromo-capsule endoscopy
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
chromo-capsule endoscopy followed by conventional capsule endoscopy
Interventions/Control_2
conventional endoscopy first, followed by chromo-capsule endoscopy
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The patients with Crohn's disease who underwent intestinal resection of all macroscopically diseased tissue
2.Candidate has to agree to be enrolled for the study under sufficient written informed consent.
Key exclusion criteria
1.Over a month of postoperative period
2.Patients with intestinal stenosis
3.Petients with severe intestinal adhesion
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Matsumoto |
Organization
Hyogo College of Medicine
Division name
Department of lower gastroenterology
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6662
hidan@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Hida |
Organization
Hyogo College of Medicine
Division name
Department of lower gastroenterology
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6662
Homepage URL
hidan@hyo-med.ac.jp
Sponsor or person
Institute
Department of lower gastroenterology, Hyogo College of Medicine
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
| 2011 | Year | 01 | Month | 17 | 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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 17 | Day |
Last modified on
| 2019 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005824
| 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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