UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Capsule endoscopy for the assessment of remaining small bowel lesions at surgery and postsurgical recurrence in patients with Crohn's disease
Title of the study (Brief title)	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	Takayuki Matsumoto
Organization	Hyogo College of Medicine
Division name	Department of lower gastroenterology
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6662
Email	hidan@hyo-med.ac.jp

Public contact
Name of contact person	Nobuyuki Hida
Organization	Hyogo College of Medicine
Division name	Department of lower gastroenterology
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6662
Homepage URL
Email	hidan@hyo-med.ac.jp

Sponsor
Institute	Department of lower gastroenterology, Hyogo College of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005824