UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015932 |
|---|---|
| Receipt number | R000018534 |
| Scientific Title | Prospective, randomized trial comparing harmonic scalpel and electrocautery in breast surgery. |
| Date of disclosure of the study information | 2014/12/17 |
| Last modified on | 2016/02/14 23:25:14 |
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Basic information
Public title
Prospective, randomized trial comparing harmonic scalpel and electrocautery in breast surgery.
Acronym
Prospective, randomized trial comparing harmonic scalpel and electrocautery in breast surgery.
Scientific Title
Prospective, randomized trial comparing harmonic scalpel and electrocautery in breast surgery.
Scientific Title:Acronym
Prospective, randomized trial comparing harmonic scalpel and electrocautery in breast surgery.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to compare the potential advantages of the harmonic scalpel with those of electrocautery for axillary lymph node dissection in breast surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of drain placement
Key secondary outcomes
The resection time,blood loss,drainage volume and seroma rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
harmonic scalpel
Interventions/Control_2
electrocautery
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
axillary lymph node metastasis
ECOG:PS 0~1
Key exclusion criteria
inflammatory breast cancer
severe underlying disease
pregnant or lantation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | tsuyoshi mori |
Organization
Shiga University of Medical Science
Division name
Department of surgery
Zip code
Address
Seta, Tsukinowa-cho, Otsu Shiga, Japan
TEL
077-548-2238
t252m@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | tsuyoshi mori |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
Address
Seta, Tsukinowa-cho, Otsu Shiga, Japan
TEL
077-548-2238
Homepage URL
t252m@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Surgery
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Other
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 | 12 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 23 | 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 | 12 | Month | 13 | Day |
Last modified on
| 2016 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018534
| Research Plan | |
|---|---|
| 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 |
