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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033101
Receipt No. R000037669
Scientific Title Prospective observational study to evaluate the usefulness of breast reconstruction combined with fat injection
Date of disclosure of the study information 2018/08/01
Last modified on 2018/06/18

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Basic information
Public title Prospective observational study to evaluate the usefulness of breast reconstruction combined with fat injection
Acronym The usefulness of breast reconstruction combined with fat injection
Scientific Title Prospective observational study to evaluate the usefulness of breast reconstruction combined with fat injection
Scientific Title:Acronym The usefulness of breast reconstruction combined with fat injection
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim in the study is to evaluate the usefulness of breast reconstruction combined with fat injection after breast resection and to achieve further optimization of treatment in the future.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative cosmetic result, QOL, and satisfaction
Key secondary outcomes

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

Not applicable
Gender Female
Key inclusion criteria Applicant for fat transfer
Key exclusion criteria The patient with infection and Advanced breast cancer
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name SOWA YOSHIHIRO
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Sciences
Division name Departments of Plastic and Reconstructive Surgery
Zip code
Address Kawaramachi-Hirokoji Kajii-cho 465, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL 075-251-5730
Email sowawan@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name SOWA YOSHIHIRO
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Sciences
Division name Departments of Plastic and Reconstructive Surgery
Zip code
Address Kawaramachi-Hirokoji Kajii-cho 465, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL 075-251-5730
Homepage URL
Email sowawan@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine, Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Sciences
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
2018 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 08 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 non

Management information
Registered date
2018 Year 06 Month 22 Day
Last modified on
2018 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037669

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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