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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027683
Receipt No. R000031513
Scientific Title Efficacy of restarting anti-TNF agents after surgery in patients with Crohn disease
Date of disclosure of the study information 2017/06/08
Last modified on 2017/12/30

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Basic information
Public title Efficacy of restarting anti-TNF agents after surgery in patients with Crohn disease
Acronym Efficacy of restarting anti-TNF agents after surgery in CD patients
Scientific Title Efficacy of restarting anti-TNF agents after surgery in patients with Crohn disease
Scientific Title:Acronym Efficacy of restarting anti-TNF agents after surgery in CD patients
Region
Japan

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

Objectives
Narrative objectives1 we investigated the patients who received anti-TNF antibodies after intestinal surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the efficacy of postoperative anti-TNF after surgery
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
10 years-old <
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria CD patients who underwent surgical resection for intestinal lesions and were administered anti-TNF agents after surgery
Key exclusion criteria surgery without anastomosis, follow-up period less than 1 year after surgery
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sakiko Hiraoka
Organization Okayama University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7219
Email sakikoh@cc.okayama-.u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sakiko Hiraoka
Organization Okayama University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7219
Homepage URL
Email sakikoh@cc.okayama-.u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine
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)

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
2017 Year 06 Month 08 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 Main results already published
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
2017 Year 04 Month 01 Day
Date of closure to data entry
2017 Year 04 Month 30 Day
Date trial data considered complete
2017 Year 05 Month 15 Day
Date analysis concluded
2017 Year 06 Month 01 Day

Other
Other related information retrospective study

Management information
Registered date
2017 Year 06 Month 08 Day
Last modified on
2017 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031513

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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