UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032885 |
|---|---|
| Receipt number | R000037384 |
| Scientific Title | A study on cost effectiveness of bariatric surgery for morbid obesity |
| Date of disclosure of the study information | 2018/06/18 |
| Last modified on | 2018/10/18 02:06:50 |
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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
| Endocrinology and Metabolism | Gastrointestinal 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
Trial characteristics_2
Pragmatic
Developmental phase
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 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 with BMI 35 or higher with or without diabetes mellitus
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
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamamoto |
Organization
Kusatsu General Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
Address
1660, Yabase, Kusatsu, Shiga, 525-8585
TEL
077-563-8866
yhiroshi@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamamoto |
Organization
Kusatsu General Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
Address
1660, Yabase, Kusatsu, Shiga, 525-8585
TEL
077-563-8866
Homepage URL
yhiroshi@belle.shiga-med.ac.jp
Sponsor or person
Institute
Kusatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kusatsu General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 18 | 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 | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 18 | Day |
Last follow-up date
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 etc.) every 6 months for 2 years after registration.
Management information
Registered date
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2018 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037384
