UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018633 |
|---|---|
| Receipt number | 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 22:39:42 |
* 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
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
m_ota@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
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
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
Value
https://center6.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 |
