UMIN-CTR Clinical Trial

Basic information
Public title	A study on cost effectiveness of bariatric surgery for morbid obesity
Acronym	Cost effectiveness of bariatric surgery
Scientific Title	A study on cost effectiveness of bariatric surgery for morbid obesity
Scientific Title:Acronym	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	390

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Yamamoto
Organization	Kohnan Hospital
Division name	Department of Surgery
Zip code	520-3321
Address	958, Katsuragi, Kohnan-cho, Koka city, Shiga
TEL	0748-86-3131
Email	yhiroshi@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Akiko Middle name Last name Saka
Organization	Kusatsu General Hospital
Division name	Clinical trial center
Zip code	525-8585
Address	1660, Yabase, Kusatsu, Shiga
TEL	077-516-2590
Homepage URL
Email	chiken@kusatsu-gh.or.jp

Sponsor
Institute	Kohnan Hospital
Institute
Department

Funding Source
Organization	Japanese Society for Treatment of Obesity/JSTO
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)

IRB Contact (For public release)
Organization	Kusatsu general hospital
Address	1660, Yabase, Kusatsu, Shiga
Tel	077-516-2590
Email	chiken@kusatsu-gh.or.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	・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）、岡崎市民病院（愛知県）、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）、武田総合病院（京都府）、大阪大学（大阪府）、関西医科大学（大阪府）、千船病院（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

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	Terminated
Date of protocol fixation	2018 Year 06 Month 20 Day
Date of IRB	2018 Year 03 Month 30 Day
Anticipated trial start date	2018 Year 08 Month 11 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

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	2022 Year 02 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038435