UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042713 |
|---|---|
| Receipt number | R000048749 |
| Scientific Title | Effectiveness of body contouring surgery for massive weight loss after bariatric surgery |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/03/27 10:42:17 |
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Basic information
Public title
Effectiveness of body contouring surgery for massive weight loss after bariatric surgery
Acronym
Effectiveness of body contouring surgery
Scientific Title
Effectiveness of body contouring surgery for massive weight loss after bariatric surgery
Scientific Title:Acronym
Effectiveness of body contouring surgery
Region
| Japan |
Condition
Condition
Patients suffering from discomfort caused by the excessive skin for massive weight loss following bariatric surgery
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate patient satisfaction of body contouring surgery for massive weight loss after bariatric surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of patient satisfaction comparing preoperative and post op. 12 month Body-Q score
Key secondary outcomes
Post operative complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
| 80 | years-old | >= |
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. 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.
3.The patient's skin condition must present a significant functional disturbance(both physical and psychological.
3.1.difficulty of physical motion
3.2.chronic shoulder pain
3.3 skin pathology
4.Refersal from bariatric surgeon or a family doctor
5. Can fill out Body-Q
6. ASA class 1 and 2
7. Currently non-smoker
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
24
Research contact person
Name of lead principal investigator
| 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
980-8575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai,
TEL
022-717-7332
yo-imai@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | koreyuki |
| Middle name | |
| Last name | Kurosawa |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
980-8575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai,
TEL
022-717-7332
Homepage URL
koreyuki.kurosawa.a1@tohoku.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
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 board of Tohoku University hospital
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
Tel
02277284105
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、千葉大形成外科、東邦大大森病院形成外科、愛媛大形成外科、大分大形成外科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | 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
| 2020 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048749
