UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011831 |
|---|---|
| Receipt number | R000013828 |
| Scientific Title | Utility of capsule endoscopy for diagnosis of small bowel obstruction; a prospective observational study |
| Date of disclosure of the study information | 2013/09/24 |
| Last modified on | 2018/12/31 23:37:17 |
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Basic information
Public title
Utility of capsule endoscopy for diagnosis of small bowel obstruction; a prospective observational study
Acronym
Utility of capsule endoscopy for diagnosis of small bowel obstruction; a prospective observational study
Scientific Title
Utility of capsule endoscopy for diagnosis of small bowel obstruction; a prospective observational study
Scientific Title:Acronym
Utility of capsule endoscopy for diagnosis of small bowel obstruction; a prospective observational study
Region
| Japan |
Condition
Condition
Small bowel obstruction
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate whether capsule endoscopic diagnosis can predict recurrence of small bowel obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate of small bowel obstruction
Key secondary outcomes
Comparison of methods for detecting patency capsule, Efficacy of patency capsule, Findings of capsule endoscopy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with diagnosis of small bowel obstruction,
2.Patients over 20 years
3.Patients who provided written informed consent
Key exclusion criteria
1.Patients who could not resolve ileus performed conservative treatment or used long tube
2.Patients with strangulation or perforation
3.Patients who performed surgery to resolve ileus
4.Patients with swallowing disorders
5.Patients with an installed pacemaker or other electromedical device
6.Pregnant patients
7.Patients who could not perform surgery according to adverse general condition when complication occurred
8.Patients with allergic reaction to barium sulfate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuo Yamada |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
yamada-a@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuo Yamada |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
yamada-a@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
東京大学医学部附属病院（東京都）（Graduate School of Medicine, The University of Tokyo）、日本赤十字社医療センター（東京都）（Japanese Red Cross Medical Center）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 06 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2013 | Year | 09 | Month | 21 | Day |
Last modified on
| 2018 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013828
