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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034595
Receipt No. R000039438
Scientific Title Clinical significance of small bowel capsule endoscopy in the evaluation of postoperative recurrence in Crohn's disease - prospective multicenter cohort study-
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/22

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Basic information
Public title Clinical significance of small bowel capsule endoscopy in the evaluation of postoperative recurrence in Crohn's disease - prospective multicenter cohort study-
Acronym Usefulness of small bowel capsule endoscopy in postoperative recurrence in Crohn's disease
Scientific Title Clinical significance of small bowel capsule endoscopy in the evaluation of postoperative recurrence in Crohn's disease - prospective multicenter cohort study-
Scientific Title:Acronym Usefulness of small bowel capsule endoscopy in postoperative recurrence in Crohn's disease
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify postoperative recurrence rates of both the anastomotic site and residual small bowel proximal to the anastomosis in Crohn's disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Positive rates of small bowel recurrence and concordance rates of anastomotic recurrence at 6 and 18 months after surgery in Crohn's disease
Key secondary outcomes

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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients with confirmed diagnosis of Crohn's disease
2. Patients with Crohn's disease who underwent small bowel resection with subsequent ileo-ileal or ileocolonic anastomosis
3. Patients who underwent surgery within 3 months
Key exclusion criteria 1. Patients who cannot be confirmed GI patency under patency capsule
2. Patients who underwent small bowel stricture plasty
3. Patients with internal or external GI fistula
4. Patients with disturbed GI motility
5. Patients under 20 years, or more than or equal to 75 years
6. Patients with cardiac pacemaker implantation
7. Patients with habitual NSAIDs consumption (including aspirin)
8. patients with malignancy, psychiatric disorder, serious liver, kidney, cardiac, or hematopoietic disorders
9. Patients during pregnancy, those suspicious of pregnancy, those with breast-feeding, or those who are planning conception
10. Patients who are judged unsuitable for the participation
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Esaki Motohiro
Organization Saga University Hospital
Division name Department of Endoscopic Diagnostics and Therapeutics
Zip code
Address Nabeshima 5-1-1, Saga city
TEL 0952-34-2374
Email mesaki01@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Esaki Motohiro
Organization Saga University Hospital
Division name Department of Endoscopic Diagnostics and Therapeutics
Zip code
Address Nabeshima 5-1-1, Saga city
TEL 0952-34-2374
Homepage URL
Email mesaki01@cc.saga-u.ac.jp

Sponsor
Institute Saga University Hospital
Institute
Department

Funding Source
Organization Saga University Hospital
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Participating institutions
1.Kyushu University
2.Iwate Medical University
3.Fukuoka University Chikushi Hospital
4.Hyogo College of Medicine
5.Fujita Health University School of Medicine
6.Nagoya University Graduate School of Medicine
7.Kyoto Prefectural University of Medicine
8.Sapporo Medical University School of Medicine
9.Graduate School of Medicine Kyoto University
10.Asahikawa Medical University
11.Tohoku University Graduate School of Medicine
12.Tokyo Womens Medical University
13.Osaka University Graduate School of Medicine
14.Okayama University Graduate School of Medicine
15.Matsuyama Red Cross Hospital
16.Mitsui Memorial hospital
17.University of Ryukyus Hospital
18.Urasoe General Hospital
19.University of Miyazaki
20.Miyazaki University Hospital
21.Nagasaki University Hospital
22.Izuro-Imamura Hospital
23.Kurume University School of Medicine
24.Jikei University School of Medicine
25.Juntendo University School of Medicine
26.Hirosaki University Graduate School of Medicine
27.Nara Medical University Hospital
28.Kyorin University School of Medicine
29.Keio University Hospital
30.Keio University School of Medicine
31.Kitasato University Kitasato Institute Hospital
32.Tokyo Medical and Dental University
33.Toho University Sakura Medical Centre

Management information
Registered date
2018 Year 10 Month 22 Day
Last modified on
2018 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039438

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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