UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042004 |
|---|---|
| Receipt number | 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 23:38:01 |
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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
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
h_ohya@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047939
