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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000030094
Receipt No. 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

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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
Email 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
Email shihokosaji@icloud.com

Sponsor
Institute Yokohama City University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034359

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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