UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034595 |
|---|---|
| Receipt number | 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 | 2021/04/24 15:33:14 |
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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 | 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
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
mesaki01@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039438
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