UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034438 |
|---|---|
| Receipt number | R000039268 |
| Scientific Title | Phase II trial on the effectiveness and safety of bariatric surgery for advanced obesity |
| Date of disclosure of the study information | 2018/10/10 |
| Last modified on | 2023/10/14 09:52:26 |
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Basic information
Public title
Phase II trial on the effectiveness and safety of bariatric surgery for advanced obesity
Acronym
Phase II trial on the effectiveness and safety of bariatric surgery
Scientific Title
Phase II trial on the effectiveness and safety of bariatric surgery for advanced obesity
Scientific Title:Acronym
Phase II trial on the effectiveness and safety of bariatric surgery
Region
| Japan |
Condition
Condition
advanced obesity
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Phase II trial on the effectiveness and safety of bariatric surgery for advanced obesity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
percent total weight loss(%TWL)
occurrence rate of adverse event
percent excess weight loss(%EVL)
improvement ratio of Obesity related complications
Health related QOL
Key secondary outcomes
Various hormones
Various cytokines
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
1. Patients 20 to 65 years
2. Patients with primary obesity
3. (a) or (b)
(a) BMI over 35 kg/m2
(b) Patients whose BMI are over 32 kg/m2 and with DM or more than one obesity-related metabolic disease
4. Patients under the active care of a doctor for at least the 6 months prior to enrollment
5. Patients judged as appropriate by obesity care team
6. ECOG Performance Status(PS) 0-1
7. Main organs function is maintained
Platelet 100,000/mm3 and over,
Serum creatinine 2.0mg/dl or under,
AST 200 IU/L or under,
ALT 200 IU/L or under,
Total bilirubin 2.0 mg/dL or under,
Hemoglobin 8.0 g/dL and over
8. Written informed consent is obtained
Key exclusion criteria
1. History of bariatric surgery
2. Currently pregnant or nursing
3. Receiving steroids or immune suppressor
4. Uncontrollable infection
5. Patients who need treatment of Ischemic heart disease
6. Liver cirrhosis of active hepatitis
7. Patients with respiratory disease and require oxygen therapy
8. Patients with renal dysfunction and require dialysis
9. Active cancer of any kind
10. Patients who have history of upper abdominal surgery and cannot accept laparoscopic surgery
11. Cases in which surgeon cannot perform safety operation
12. Patients uncooperative to treatment
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
tojima@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Fukuda |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
Homepage URL
n-fukuda@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama
Tel
073-447-2300
wa-rinri@wakayama-med.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2018 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039268
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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