UMIN-CTR Clinical Trial

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