UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033705 |
|---|---|
| Receipt number | R000038435 |
| Scientific Title | A study on cost effectiveness of bariatric surgery for morbid obesity |
| Date of disclosure of the study information | 2018/08/11 |
| Last modified on | 2022/02/19 12:42:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
chiken@kusatsu-gh.or.jp
Sponsor or person
Institute
Kohnan Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038435
