UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of capsule endoscopy for diagnosis of small bowel obstruction; a prospective observational study
Title of the study (Brief title)	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	Atsuo Yamada
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	yamada-a@umin.ac.jp

Public contact
Name of contact person	Atsuo Yamada
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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