Unique ID issued by UMIN | UMIN000039418 |
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Receipt number | R000044714 |
Scientific Title | MAnagement of Direct Oral anticoagulant (DOACs) While Peripolypectomy Period: randomized A randomized controlled, mUlticenter trial |
Date of disclosure of the study information | 2020/02/08 |
Last modified on | 2020/02/19 02:14:09 |
A randomized controlled, multicenter trial investigating management of Direct Oral anticoagulant (DOACs) for colorectal polypectomy
A randomized controlled trial on management of DOACs.
MAnagement of Direct Oral anticoagulant (DOACs) While Peripolypectomy Period: randomized A randomized controlled, mUlticenter trial
A randomized controlled trial on management of DOACs.
Japan |
Colorectal polyp
Gastroenterology |
Malignancy
NO
To determine the optimal administration period of Direct Oral Anticoagulants (DOACs) during the perioperative period of colon polypectomy.
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
Rate of severe bleeding (uncontrolled intraoperative and postoperative bleeding) associated with polypectomy.
Rate of postoperative bleeding without emergency endoscopic hemostasis after polypectomy
Rate of bleeding requiring blood cessation immediately after polypectomy
DOAC dose intensity ( dose intensity)
The rate of bleeding in patients who underwent only Cold Snare / Forceps Polypectomy
The rate of bleeding by the type of DOAC, the rate of adverse events (the rate of thromboembolism, Incidence).
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Group to discontinuing DOACs for 1 day before lower endoscopy
Group to discontinue DOACs for 1 day after endoscopic resection
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1 Person > 20 , < 80 years old
2 Patients taking direct oral anticoagulants (DOACs)
3 Appropriate informed consent.
4 PS, 0 or 1.
5 Blood test data
Platelet count > 100,000
Serum creatinine < 2.0mg / dl
PT% > 40%
6 Follow up of 30 days after treatment.
Note: Registration is possible even in cases after colorectal surgery.
1 Person who has registered in this test.
2 Inflammatory bowel disease, colon polyposis.
3 Patients are receiving systemic steroids, antiplatelet drugs, and multiple anticoagulants continuously. (However, patients who can respond to antiplatelet drugs according to the guidelines of the Japanese Endoscopy Society can be registered.)
4 Blood coagulation dysfunction disease.
5 Women who are pregnant, may become pregnant, or are breastfeeding.
6 Patients with psychosis or psychiatric symptoms seem to have difficulty participating in the study.
7 Active bacterial and fungal infection (has a fever of 38.5 degrees or higher and is associated with bacterial infectivity by diagnostic imaging or bacteriological examination).
8 Uncontrolled hypertension.
9 Respiratory disease requiring continuous oxygen administration.
10 Dialysis.
11 Others who are judged inappropriate by the attending physician (eg, the prescribing physician of the anticoagulant determined that participation in this study was dangerous).
400
1st name | Yoji |
Middle name | |
Last name | Takeuchi |
Osaka International Cancer Institute
Department of Gastrointestinal Oncology
541-8567
Chuoku
0669451181
yoji.endoscopy@oici.jp
1st name | Mitsuhiro |
Middle name | |
Last name | Kono |
Osaka International Cancer Institute
Department of Gastrointestinal Oncology
541-8567
Chuoku
0669451181
bokuri.1229@gmail.com
Osaka International Cancer Institute
Japan Gastroenterological Association
Other
Madowazu investigators
Medical research support
3-1-69 Otemae, Chuo-ku, Osaka
0669451181
rinri01@opho.jp
NO
2020 | Year | 02 | Month | 08 | Day |
Unpublished
Enrolling by invitation
2019 | Year | 10 | Month | 31 | Day |
2019 | Year | 12 | Month | 25 | Day |
2020 | Year | 03 | Month | 01 | Day |
2023 | Year | 02 | Month | 28 | Day |
2020 | Year | 02 | Month | 06 | Day |
2020 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044714
Research Plan | |
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Registered date | File name |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2023/03/31 | MADOWAZU trial_UMIN用シート別(医師名、識別番号、イニシャル、生年月日無し)20230322.xlsx |