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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031796
Receipt No. R000036298
Scientific Title Safety and effectiveness of body contouring surgery after massive weight loss
Date of disclosure of the study information 2018/06/01
Last modified on 2019/04/10

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Basic information
Public title Safety and effectiveness of body contouring surgery after massive weight loss
Acronym Safety and effectiveness of body contouring surgery
Scientific Title Safety and effectiveness of body contouring surgery after massive weight loss
Scientific Title:Acronym Safety and effectiveness of body contouring surgery
Region
Japan

Condition
Condition Patients suffering from the discomfort caused by the excessive loose skin following massive weight loss
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate patient satisfaction and complication rate of body contouring surgeries when performed on patients with weight loss
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Assessment of body contouring by photograph at post op. 6 month, 12month
Key secondary outcomes 1. Post operative conplications 2. Patient satisfaction at post op. 6 month, 12month

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 surgical resection of skin fold
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 Male and Female
Key inclusion criteria 1. Patients suffering from skin folds after massive weight loss
2. Patients are followed over one year after massive weight loss
3. Consecutive 3 monthly body weight changes are within 5 % of excessive body weight. The calculation of excessive body weight are pre-treatment weight minus ideal body weight.
Key exclusion criteria 1, severe cardiac failure, major pulmonary dysfunction
2, patients who cannot be followed or denied to be followed up
3, pregnant patients
4, patients with coagulopathy
5, patients who are attending other experimental protocol
Target sample size 7

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Masahiro
Organization Graduate School of
Medicine, Tohoku University
Division name Department of Plastic and Reconstructive Surgery
Zip code 9808574
Address 2-1, Seiryo-machi, Aoba-ku, Sendai,
TEL 0227177748
Email tachi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Yoshimichi
Middle name
Last name Imai
Organization Graduate School of Medicine, Tohoku University
Division name Department of Plastic and Reconstructive Surgery
Zip code 9808574
Address 2-1, Seiryo-machi, Aoba-ku, Sendai,
TEL 0227177748
Homepage URL
Email yo-imai@med.tohoku.ac.jp

Sponsor
Institute Graduate School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization Management Expenses Grants
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 ethical boad of Tohoku University hospital
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
Tel 02277284105
Email rinri-esct@proj.med.tohoku.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 東北大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 06 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2018 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 19 Day
Last modified on
2019 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036298

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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