UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033749
Receipt No. 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 2019/01/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ch-son@hyo-med.ac.jp

Sponsor
Institute Hyogo college of Medicine
Institute
Department

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
Email

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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 14 Day
Last modified on
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038478

Research Plan
Registered date File name
2019/01/21 VTE予防におけるエノキサパリンの有効性の検討 v1.0【FIX】.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.