UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014645 |
|---|---|
| Receipt number | R000016988 |
| Scientific Title | Safety and effectiveness of body contouring surgery after bariatric surgery |
| Date of disclosure of the study information | 2014/07/28 |
| Last modified on | 2018/08/10 17:32:59 |
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Basic information
Public title
Safety and effectiveness of body contouring surgery after bariatric surgery
Acronym
Body contouring surgery after bariatric surgery
Scientific Title
Safety and effectiveness of body contouring surgery after bariatric surgery
Scientific Title:Acronym
Body contouring surgery after bariatric surgery
Region
| Japan |
Condition
Condition
Patients suffering from the discomfort caused by the excessive loose skin following bariatric surgery
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 due to bariatric surgeries
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 caused by bariatric surgery
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 bariatric surgery.
2. Patients are followed over one year after bariatric surgery.
3. Consecutive 3 monthly body weight changes are within 5 % of excessive body weight. The calculation of excessive body weight are pre-bariatric surgery 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
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Tachi |
Organization
Graduate School of
Medicine, Tohoku University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai,
TEL
0227177748
tachi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Imai |
Organization
Graduate School of
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai,
TEL
0227177748
Homepage URL
yo-imai@med.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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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（宮城県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 28 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 21 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 25 | Day |
Last modified on
| 2018 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016988
