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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033705
Receipt No. R000038435
Official scientific title of the study A study on cost effectiveness of bariatric surgery for morbid obesity
Date of disclosure of the study information 2018/08/11
Last modified on 2018/08/09

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Basic information
Official scientific title of the study A study on cost effectiveness of bariatric surgery for morbid obesity
Title of the study (Brief title) Cost effectiveness of bariatric surgery
Region
Japan

Condition
Condition Morbid obesity
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the cost-effectiveness of bariatric surgery for morbid obesity
Basic objectives2 Others
Basic objectives -Others To clarify the effect of bariatric surgery on medical expenses, QOL and metabolic indicators, leading to medical economic effects in morbid obesity patients in Japan
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Medical expenses for 2 years from registration
Patient's background at registration, and QOL survey (SF-36 and EQ-5D) every 3 months for 2 years after registration.
Metabolic indicators (HbA1c, presence and content of medication including antidiabetics and insulin, BMI, C peptide, history of diabetes mellitus etc.), SBP/DBP, HR, AST, ALT, TCHO, HDL, LDL, TG, UA, Cre, BS etc. every 6 months for 2 years after registration.
Key secondary outcomes

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
65 years-old >
Gender Male and Female
Key inclusion criteria Morbid obesity individuals resistant to medical treatment for more than 6 months, with BMI 35 or higher, with either diabetes mellitus, hypertension, dyslipidemia or sleep apnea.
For surgical treatment group, patients who underwent laparoscopic sleeve gastrectomy using public health insurance
Key exclusion criteria Treatable secondary obese patients.
Pregnant women or patients who may be pregnant.
Patients who can not obtain written consent
Target sample size 220

Research contact person
Name of lead principal investigator Hiroshi Yamamoto
Organization Kusatsu General Hospital
Division name Department of Gastrointestinal Surgery
Address 1660, Yabase, Kusatsu, Shiga, 525-8585
TEL 077-563-8866
Email yhiroshi@belle.shiga-med.ac.jp

Public contact
Name of contact person Hiroshi Yamamoto
Organization Kusatsu General Hospital
Division name Department of Gastrointestinal Surgery
Address 1660, Yabase, Kusatsu, Shiga, 525-8585
TEL 077-563-8866
Homepage URL
Email yhiroshi@belle.shiga-med.ac.jp

Sponsor
Institute Kusatsu General Hospital
Institute
Department

Funding Source
Organization Kusatsu General Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Japanese Society for Treatment of Obesity/JSTO
Name of secondary funder(s)

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 ・岩手医科大学(岩手県)、自治医科大学(栃木県)、埼玉医科大学(埼玉県)、多摩総合医療センター(東京都)、慶応大学(東京都)、四谷メディカルキューブ(東京都)、東邦大学医療センター 佐倉病院(千葉県)、千葉大学(千葉県)、滋賀医科大学(滋賀県)、草津総合病院(滋賀県)、京都医療センター(京都府)、大阪大学(大阪府)、関西医科大学(大阪府)、九州大学(福岡県)、大分大学(大分県)、大浜第一病院(沖縄県)、立命館大学(滋賀県)、福岡大学(福岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 11 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 20 Day
Anticipated trial start date
2018 Year 08 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Medical expenses for 2 years from registration
Patient's background, QOL survey (SF-36) and utility value (EQ-5D) every 3 months for 2 years after registration.
Metabolic indicators (HbA1c, presence and content of medication including antidiabetics and insulin, BMI, C peptide, history of diabetes mellitus, SBP/DBP, HR, AST, ALT, TCHO, HDL, LDL, TG, UA, Cre, BS etc.) every 6 months for 2 years after registration.

Management information
Registered date
2018 Year 08 Month 09 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038435

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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