UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	DIEP flap breast reconstruction in lithotomy position
Title of the study (Brief title)	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	Shihoko Saji
Organization	Yokohama City University Medical Center
Division name	Plastic and reconstructive surgery
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	Shihoko Saji
Organization	Yokohama City University Medical Center
Division name	Plastic and reconstructive surgery
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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