UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002720 |
|---|---|
| Receipt number | R000003026 |
| Scientific Title | Introduction of bariatric surgery for morbid obesity |
| Date of disclosure of the study information | 2009/11/06 |
| Last modified on | 2009/11/06 15:54:02 |
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Basic information
Public title
Introduction of bariatric surgery for morbid obesity
Acronym
Introduction of bariatric surgery for morbid obesity
Scientific Title
Introduction of bariatric surgery for morbid obesity
Scientific Title:Acronym
Introduction of bariatric surgery for morbid obesity
Region
| Japan |
Condition
Condition
morbid obesity
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Introduction of bariatric surgery for morbid obesity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of operation
Key secondary outcomes
Rate of post-operative morbidity, efficacy of body weight reduction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Operation
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with BMI greater than 37 or with BMI greater than 32 having complications such as hypertension, hyperlipidemia, and diabetes. Patients hoping to undergo operation with understanding of bariatric surgery
Key exclusion criteria
(1) Patients whose obesity has something to do with psychological diseases. (2) Patients in whom efficacy of bariatric surgery was judged as insufficient. (3) Patients judged as having no indication for operation.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shibata Chikashi |
Organization
Tohoku University Postgraduate School of Medicine
Division name
Division of Biological Regulation and Oncology. Department of Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku Sendai 980-8574, Miyagi, Japan
TEL
022-717-7205
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shibata Chikashi |
Organization
Tohoku University Postgraduate School of Medicine
Division name
Division of Biological Regulation and Oncology. Department of Surgery
Zip code
Address
TEL
Homepage URL
cshibata@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Postgraduate School of Medicine
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
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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 06 | Day |
Last modified on
| 2009 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003026
