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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034438
Receipt No. 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 2018/10/10

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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
Middle name
Last name Toshiyasu Ojima
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama
TEL 073-447-2300
Email tojima@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Fukuda
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama
TEL 073-447-2300
Homepage URL
Email n-fukuda@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 10 Month 10 Day
Last follow-up date
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
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039268

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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