UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033663 |
|---|---|
| Receipt number | R000038372 |
| Scientific Title | Retrospective study of preoperative deep vein thrombosis risk factors in patients with colorectal cancer |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2019/08/13 23:00:36 |
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Basic information
Public title
Retrospective study of preoperative deep vein thrombosis risk factors in patients with colorectal cancer
Acronym
Retrospective study of preoperative deep vein thrombosis risk factors in patients with colorectal cancer
Scientific Title
Retrospective study of preoperative deep vein thrombosis risk factors in patients with colorectal cancer
Scientific Title:Acronym
Retrospective study of preoperative deep vein thrombosis risk factors in patients with colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the preoperative prevalence and risk factors of deep vein thrombosis by using lower extremity venous ultrasonography in patients for colorectal cancer surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preoperative prevalence of deep vein thrombosis
Key secondary outcomes
Risk factors of deep vein thrombosis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent colorectal cancer surgery from January of 2013 to March of 2017 at our hospital
Key exclusion criteria
1)Emergency surgery
2)Not performed preoperative lower limb ultrasonography
3)Not mesuered preoperative serum D-dimer
4)Postoperative hospital death (within 30 days)
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Yokohama City University Medical Center
Division name
Department of Surgery, Gastroenterological Center
Zip code
2320024
Address
4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan
TEL
045-261-5656
nabe-jun@comet.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Nakagawa |
Organization
Yokohama City University Medical Center
Division name
Department of Surgery, Gastroenterological Center
Zip code
2320024
Address
4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan
TEL
045-261-5656
Homepage URL
nakagawakazuya0827@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yokohama Clinical Oncology Group(YCOG)
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
Ethics Committee of Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
045-370-7627
nextjim1@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
| 2018 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1006
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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate preoperative prevalence and risk factors of deep vein thrombosis by using lower extremity venous ultrasonography in patients for colorectal cancer surgery
Management information
Registered date
| 2018 | Year | 08 | Month | 07 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038372
