UMIN-CTR Clinical Trial

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
Email	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
Email	koreyuki.kurosawa.a1@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 board 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、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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048749