UMIN-CTR Clinical Trial

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 Motohiro Middle name Last name Esaki
Organization	Saga University Hospital
Division name	Department of Endoscopic Diagnostics and Therapeutics
Zip code	849-8501
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 Motohiro Middle name Last name Esaki
Organization	Saga University Hospital
Division name	Department of Endoscopic Diagnostics and Therapeutics
Zip code	849-8501
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	Saga University hospital
Address	Nabeshima 5-1-1, Saga city
Tel	0952-34-2374
Email	mesaki01@cc.saga-u.ac.jp

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	2018 Year 08 Month 28 Day
Anticipated trial start date	2018 Year 08 Month 28 Day
Last follow-up date	2023 Year 12 Month 31 Day
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.Kanazawa Medical Center 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.Kanazawa University 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.Hirosaki University Graduate School of Medicine 26.Nara Medical University Hospital 27.Kyorin University School of Medicine 28.Keio University Hospital 29.Keio University School of Medicine 30.Kitasato University Kitasato Institute Hospital 31.Tokyo Medical and Dental University 32.Toho University Sakura Medical Centre 33.Kagoshima University 34. Yokohama municipal citizen's hospital

Management information
Registered date	2018 Year 10 Month 22 Day
Last modified on	2021 Year 04 Month 24 Day

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