UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033749 |
|---|---|
| Receipt number | R000038478 |
| Scientific Title | The study of he efficacy of combination enoxaparin and physical therapy for perioperative venous thrombosis (VTE) prevention after laparoscopic colon cancer surgery |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2024/08/20 17:37:25 |
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Basic information
Public title
The study of he efficacy of combination enoxaparin and physical therapy for perioperative venous thrombosis (VTE) prevention after laparoscopic colon cancer surgery
Acronym
The study of he efficacy of combination enoxaparin and physical therapy for perioperative venous thrombosis (VTE) prevention after laparoscopic colon cancer surgery
Scientific Title
The study of he efficacy of combination enoxaparin and physical therapy for perioperative venous thrombosis (VTE) prevention after laparoscopic colon cancer surgery
Scientific Title:Acronym
The study of he efficacy of combination enoxaparin and physical therapy for perioperative venous thrombosis (VTE) prevention after laparoscopic colon cancer surgery
Region
| Japan |
Condition
Condition
venous thromboembolism (VTE)
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness and safety of administration of Enoxaparin for prevention of venous thromboembolism after surgery for colorectal cancer patients subject to radical surgery by laparoscopy
Basic objectives2
Others
Basic objectives -Others
Investigate whether invasion of intermettent pneumatic compression used for perioperative VTE prevention or surgery itself is a risk factor for HIT antibody production
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of expression of VTE after colon resection
Key secondary outcomes
1. Presence or absence of Major bleeding
2. Presence or absence of Minor bleeding
3. Measurement result of anti-PF4 / heparin antibody
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Standard physiotherapy groups such as intermittent pneumatic compression (IPC), wearing elastic stockings and early exit and active exercise
Interventions/Control_2
A group using a combination of standard physical therapy and anticoagulation therapy using Enoxaparin (Clexane)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with colorectal cancer
2. Patients over 40 years old
3. Patients scheduled to undergo radical surgery by laparoscopy
4. Patient who can acquire document consent from the person himself or his substitute
Key exclusion criteria
1. Patient who is bleeding
2. Patients with complications that may cause bleeding (excluding diseases subject to surgery)
3. Patient who does not retain main organ function (measured within 42 days before registration date by blood test)
4. Patients whose history of hypersensitivity to the test drug components, heparin, heparin derivatives (low molecular weight heparin, etc.) has been confirmed
5. Patients with a history of cerebral hemorrhage
6. Patients who underwent surgery of the central nervous system (brain, spine) or ophthalmic surgery (excluding cataract surgery) within 3 months before the trial registration
7. Patients with contrast medium allergy
8. Patients with a history of heparin-induced thrombocytopenia (HIT)
9. Patients who underwent major orthopedic surgery, abdominal surgery or cardiovascular surgery on the lower extremities within 3 months prior to registration of this study
10. In this study, patients who received the following combination prohibited drug within one week before registration
(Heparin, low molecular weight heparin, danaparoid, antithrombin agent, warfarin, thrombolytic agent, antiplatelet drug)
11. Patients requiring heparin substitution during the perioperative period
12. In preoperative examination, patients diagnosed with VTE
13. Patients with a history of arterial thromboembolism (including cerebral infarction and myocardial infarction)
14. Patients with drug dependence or alcoholism
15. Patients who are planning other surgical operations during the study period
16. Patients who are pregnant or have a possibility of pregnancy
17. Patients participating in other clinical trials at the same time as this study (except observational research)
18. Other patients who are judged inappropriate by the examination responsible doctor or the test sharing doctor as the examination subject
Target sample size
302
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Ikeda |
Organization
Hyogo College of Medicine
Division name
Division of Lower gastrointestinal Surgery
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya 663-8501, Japan
TEL
0798-45-6372
ms-ikeda@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jihyung Song |
Organization
Hyogo College of Medicine
Division name
Division of Lower gastrointestinal Surgery
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya 663-8501, Japan
TEL
0798-45-6372
Homepage URL
ch-son@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cerebral and Cardiovascular Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
明和病院（兵庫県）、兵庫県立がんセンター（兵庫県）、製鉄記念広畑病院（兵庫県）、神鋼記念病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 01 | 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
310
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 07 | Month | 16 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 14 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038478
