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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042004
Receipt No. R000047939
Scientific Title A retrospective observational study on diagnosis and treatment of perioperative thrombosis in surgical patients for inflammatory bowel disease
Date of disclosure of the study information 2020/10/05
Last modified on 2020/10/04

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Basic information
Public title A retrospective observational study on diagnosis and treatment of perioperative thrombosis in surgical patients for inflammatory bowel disease
Acronym A retrospective observational study on diagnosis and treatment of perioperative thrombosis in surgical patients for inflammatory bowel disease
Scientific Title A retrospective observational study on diagnosis and treatment of perioperative thrombosis in surgical patients for inflammatory bowel disease
Scientific Title:Acronym A retrospective observational study on diagnosis and treatment of perioperative thrombosis in surgical patients for inflammatory bowel disease
Region
Japan

Condition
Condition Inflammatory bowel disease
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the risk of perioperative thrombosis in surgical patients for inflammatory bowel disease by comparing it with colorectal cancer patients who are considered to be at high risk of pulmonary thromboembolism and deep vein thrombosis.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The prevalence of preoperative deep vein thrombosis in surgical cases for inflammatory bowel disease
Key secondary outcomes The prevalence of preoperative pulmonary thromboembolism in surgical cases for inflammatory bowel disease, the prevalence of preoperative arterial and venous thrombosis in surgical cases for inflammatory bowel disease, the investigation of risk factors for preoperative arterial and venous thrombosis in surgical cases for inflammatory bowel disease, the examination of diagnostic methods for preoperative arterial and venous thrombosis in surgical cases for inflammatory bowel disease, the examination of safety and efficacy of treatment for preoperative arterial and venous thrombosis in surgical cases for inflammatory bowel disease, the examination of postoperative thrombotic complications and treatment outcomes in surgical cases for inflammatory bowel disease, the examination of postoperative hemorrhagic complications and treatment results in surgical cases for inflammatory bowel disease, the examination of risk factors for postoperative arterial and venous thrombosis in surgical cases for inflammatory bowel disease, the examination of diagnostic methods for postoperative arterial and venous thrombosis in surgical cases for inflammatory bowel disease, the examination of safety and efficacy of treatment for postoperative arterial and venous thrombosis in surgical cases of inflammatory bowel disease, the examination of perioperative arterial and venous thrombosis in children and the elderly, the examination of perioperative arterial and venous thrombosis in patients with comorbidities (e.g., heart disease, lung disease, oral antiplatelet drug.)

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent surgical treatment for inflammatory bowel disease or colorectal cancer at our hospital between January 2000 and December 2019
Key exclusion criteria Patients in emergency surgery who could not be tested for thrombus before surgery, Patients with preoperative D-dimer less than 1.0 ug/ml who have not undergone lower extremity venous ultrasonography
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Hideaki
Middle name
Last name Kimura
Organization Yokohama City University Medical Center
Division name Inframmatory Bowel Disease Center
Zip code 232-0024
Address 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024. Japan
TEL 045-261-5656
Email hkim@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Ohya
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code 232-0024
Address 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024. Japan
TEL 045-261-5656
Homepage URL
Email h_ohya@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
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 Ethics Committee of Yokohama City University
Address 3-9, Fukuura Kanazawa-ku Yokohama
Tel 045-370-7627
Email rinri@yokohama-cu.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
2020 Year 10 Month 05 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2025 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The subjects have undergone surgery for inflammatory bowel disease or colorectal cancer and whose D-dimer value is measured preoperatively. With a cutoff value of 1.0 ug / ml for D-dimer, lower limb venous ultrasonography is performed for D-dimer-positive cases to search for deep vein thrombosis. Compare the prevalence of preoperative deep vein thrombosis in surgical cases of inflammatory bowel disease and colorectal cancer.

Management information
Registered date
2020 Year 10 Month 04 Day
Last modified on
2020 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047939

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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