UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030094 |
|---|---|
| Receipt number | R000034359 |
| Scientific Title | DIEP flap breast reconstruction in lithotomy position |
| Date of disclosure of the study information | 2017/11/24 |
| Last modified on | 2017/11/23 20:21:38 |
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Basic information
Public title
DIEP flap breast reconstruction in lithotomy position
Acronym
DIEP flap breast reconstruction in lithotomy position
Scientific Title
DIEP flap breast reconstruction in lithotomy position
Scientific Title:Acronym
DIEP flap breast reconstruction in lithotomy position
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Some papers state that flap harvest and breast mastectomy can be accomplished simultaneously in immediate DIEP flap breast reconstruction, to reduce operative time. However, this is not always the case, especially in Asian patients who tend to be shorter than other races. There is not enough working space for breast surgeons and plastic surgeons to perform surgery simultaneously. We attempted to solve this problem by placing the patient in lithotomy position.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We evaluated patients that underwent immediate DIEP flap breast reconstruction in supine or lithotomy position, between October 2014 and July 2016, performed by the same operator in the same hospital.
Key secondary outcomes
Complication caused by the position
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
patients who underwent immediate DIEP flap breast reconstruction in supine or lithotomy position, between October 2014 and July 2016, performed by the same operator in the same hospital
Key exclusion criteria
patial mastectomy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shihoko Saji |
Organization
Yokohama City University Medical Center
Division name
Plastic and reconstructive surgery
Zip code
Address
C504, 3211 Kozukue-Cho, Kohoku-Ku, Yokohama City, Kanagawa Prefecture, Japan
TEL
080-5182-0666
shihokosaji@icloud.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shihoko Saji |
Organization
Yokohama City University Medical Center
Division name
Plastic and reconstructive surgery
Zip code
Address
C504, 3211 Kozukue-Cho, Kohoku-Ku, Yokohama City, Kanagawa Prefecture, Japan
TEL
080-5182-0666
Homepage URL
shihokosaji@icloud.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2017 | Year | 11 | Month | 24 | 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
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
Main results already published
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of patients who underwent immediate DIEP flap breast reconstruction in supine or lithotomy position, between October 2014 and July 2016, performed by the same operator in the same hospital.
Management information
Registered date
| 2017 | Year | 11 | Month | 23 | Day |
Last modified on
| 2017 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034359
| 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 |
