UMIN-CTR Clinical Trial

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

venous thromboembolism (VTE)

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hyogo college of Medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

National Cerebral and Cardiovascular Center

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2018

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

08

Month

14

Day

Last modified on

2019

Year

01

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038478