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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020268
Receipt No. R000023283
Scientific Title Joint research study about capsular formation of tissue expander for breast reconstruction
Date of disclosure of the study information 2016/04/01
Last modified on 2019/06/21

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Basic information
Public title Joint research study about capsular formation of tissue expander for breast reconstruction
Acronym tissue expander and capsular formation
Scientific Title Joint research study about capsular formation of tissue expander for breast reconstruction
Scientific Title:Acronym tissue expander and capsular formation
Region
Japan

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

Objectives
Narrative objectives1 research study about capsular formation of tissue expander
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Examination of adhesion rate between tissue expander and peripheral tissue at removal operation of tissue expander.
Key secondary outcomes serous fluid volume from sump drain, complication rate

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 Patients who are transplanted Tissue Expander under the pectoralis major muscle in the first breast reconstruction surgery.
Key exclusion criteria 1. Past history of breast reconstruction surgery in the same side.
2. Patients who are deemed inappropriate by principal physician because of her mental condition or social background.
3. Patients who are transplanted Tissue Expander except under the pectoralis major muscle.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Motone
Middle name
Last name Kuriyama
Organization Shin Yurigaoka General Hospital
Division name Plastic and Reconstructive Surgery
Zip code 215-0026
Address 255, Koto, Furusawa, Asao-ku, Kawasaki-city, Kanagawa, Japan
TEL 044-322-9991
Email motone.ku@gmail.com

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Yano
Organization Kochi Medical School Hospital
Division name Plastic and Reconstructive Surgery
Zip code 783-8505
Address 185-1, Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL 088-880-2375
Homepage URL
Email jm-y.akiko@kochi-u.ac.jp

Sponsor
Institute Chugoku-Shikoku Society of Society of Plastic and Reconstructive Surgery
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kochi Medical School Hospital
Address 185-1, Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
Tel 088-880-2180
Email rinri21@kochi-u.ac.jp

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 高知大学医学部附属病院,(高知県),岡山大学病院(岡山県),四国がんセンター(愛媛県),広島市民病院(広島県),福山市民病院(広島県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 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 No longer recruiting
Date of protocol fixation
2015 Year 09 Month 13 Day
Date of IRB
2015 Year 10 Month 27 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 06 Month 30 Day
Date trial data considered complete
2018 Year 07 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information Design: Cohort study
Subject: From April 1 2016 to March 31 2017, All patients who are transplanted tissue expander under the pectoralis major muscle for breast reconstruction in Kochi Medical School Hospital and cooperation facilities.
Investigation period: from April 1 2016 to March 31 2018.
Investigation item: Adhesion area between Tissue Expander and peripheral tissue.

Management information
Registered date
2015 Year 12 Month 18 Day
Last modified on
2019 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023283

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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