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Recruitment status Completed
Unique ID issued by UMIN UMIN000011831
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email yamada-a@umin.ac.jp

Sponsor
Institute Graduate School of Medicine, The University of Tokyo
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013828


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