UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018633
Receipt No. R000021565
Scientific Title Randomized Phase II trial of Enoxiaparin Sodium for the Prevension of Postoperative Venous Thromboembolism after Laparoscopic Colorectal Cancer Surgery (ENVELOPE study)
Date of disclosure of the study information 2015/08/15
Last modified on 2019/08/13

* 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 Randomized Phase II trial of Enoxiaparin Sodium for the Prevension of Postoperative Venous Thromboembolism after Laparoscopic Colorectal Cancer Surgery (ENVELOPE study)
Acronym Randomized Phase II trial of Enoxiaparin Sodium for the Prevension of Postoperative Venous Thromboembolism after Laparoscopic Colorectal Cancer Surgery (ENVELOPE study)
Scientific Title Randomized Phase II trial of Enoxiaparin Sodium for the Prevension of Postoperative Venous Thromboembolism after Laparoscopic Colorectal Cancer Surgery (ENVELOPE study)
Scientific Title:Acronym Randomized Phase II trial of Enoxiaparin Sodium for the Prevension of Postoperative Venous Thromboembolism after Laparoscopic Colorectal Cancer Surgery (ENVELOPE study)
Region
Japan

Condition
Condition Colon cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify incidence of venos thromboembolism and rate of bleeding events and to evaluate efficacy and safety of enoxaparin after laparoscopic colon cancer surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Incidence of venos thromboembolism until postoperative day 28
Key secondary outcomes 1) Rate of bleeding events until discharge
2) Incidence of venos thromboembolism until discharge
3) Incidence of postoperative complications excluded venos thromboembolism

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Enoxaparin group
Subcutaneous injection of enoxaparin 2000U twice daily (postoperative day 2 to discharge)
Intermittent pneumatic compression (IPC) prophylaxis (after surgery to postoperative day 1)
Interventions/Control_2 Control group
IPC prophylaxis alone (after surgery to postoperative day 1)
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 1. Age of 20 years or older
2. Peformance status: 0 or 1
3. Elective laparoscopic colon cancer surgery
4. Tumor location: C, A, T, D, S, RS
5. No distant metastases by preoperative image findings within 28 days before registration
6. No deep venos thrombosis by preoperative ultrasonography within 28 days before registration
7. No preoperative treatment ( radiation, chemotherapy, etc)
8. Written informed consent after receiving explanation of the study
Key exclusion criteria 1. Cotraindications of enoxaparin
-Allergy for enoxaparin, heparin, and heparin derivatives
-Bleeding or bleeding suspected
-Acute bacterial endocarditis
-Severe renal dysfunction
-History of heparin-induced thrombocytopenia (HIT)
2. History of VTE
3. Receiving anticoagulants or antiplatelet drugs
4. Allergy for contrast media
5. Petients who are considered to be inappropriate for this trial by doctor
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Itaru
Middle name
Last name Endo
Organization Yokohama City University Hospital
Division name Gastroenterological surgery
Zip code 2360004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Email endoit@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Mitsuyoshi
Middle name
Last name Ota
Organization Yokohama City University Medical Center
Division name Gastroenerological Center
Zip code 2320024
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email m_ota@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
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 Medical Center
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
Tel 045-253-5303
Email u_syomu@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 横浜市立大学附属市民総合医療センター(神奈川県)、横浜市立大学附属病院(神奈川県)、横須賀共済病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 15 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 121
Results Incidence of venous thromboembolism (VTE) on the postoperative 28th days was 12.3% (7/57 patients) in the enoxaparin group and 11.9% (7/59 patients) in the IPC group.
Results date posted
2019 Year 08 Month 13 Day
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
2014 Year 07 Month 31 Day
Date of IRB
2015 Year 08 Month 01 Day
Anticipated trial start date
2015 Year 08 Month 15 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

Management information
Registered date
2015 Year 08 Month 10 Day
Last modified on
2019 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021565

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.