UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013034 |
|---|---|
| Receipt number | R000015207 |
| Scientific Title | Utility of vessel-sealing systems in reducing serous drainage after axillary dissecton for breast surgery : A prospective randomized study |
| Date of disclosure of the study information | 2014/02/03 |
| Last modified on | 2015/08/10 10:11:54 |
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Basic information
Public title
Utility of vessel-sealing systems in reducing serous drainage after axillary dissecton for breast surgery :
A prospective randomized study
Acronym
Utility of vessel-sealing systems in reducing serous drainage after axillary dissecton for breast surgery :
A prospective randomized study
Scientific Title
Utility of vessel-sealing systems in reducing serous drainage after axillary dissecton for breast surgery :
A prospective randomized study
Scientific Title:Acronym
Utility of vessel-sealing systems in reducing serous drainage after axillary dissecton for breast surgery :
A prospective randomized study
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare safety and efficacy of a vessel sealing system (LigaSure Small Jaw) to the conventional technique in axillary lymph nodes dissection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of removing drain after surgery
Key secondary outcomes
Total drainage volume
Intraoperative blood loss
Safety: incidence of postoperative surgical complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Vessel-sealing system (LigaSure Small Jaw) (Study group)
Interventions/Control_2
Conventional treatment (Control group)
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Pathologically confirmed breast cancer who diagnosed
2) Age: >=20 and <=80
3) Written informed consent
Key exclusion criteria
1) Planned to breast reconstruction surgery
2) Post sentinel node biopsy
3) Patients who take anticoagulants or antiplatelet agents
4) Patients with severe hepatic disease.
5) Patients with severe kidney disease.
6) Pregnant and women who may be pregnant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Tokuda |
Organization
Tokai University school of medicine
Division name
Department Breast and Endocrine Surgery
Zip code
Address
143 Shimokasuya Isehara Kanagawa
TEL
0463-93-1121
tokuda@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuho Okamura |
Organization
Tokai University school of medicine
Division name
Department Breast and Endocrine Surgery
Zip code
Address
143 Shimokasuya Isehara Kanagawa
TEL
0463-93-1121
Homepage URL
takuho@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University school of medicine Department of Breast Endocrine Surgery
Institute
Department
Personal name
Funding Source
Organization
Tokai University school of medicine
Department of Breast Endocrine Surgery
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
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 03 | 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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 05 | 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
| 2014 | Year | 01 | Month | 31 | Day |
Last modified on
| 2015 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015207
