UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006282 |
|---|---|
| Receipt number | R000007434 |
| Scientific Title | The safety and usefulness of Bariatric surgery(laparoscopic sleeve gastrectomy) |
| Date of disclosure of the study information | 2011/09/16 |
| Last modified on | 2011/09/05 09:29:48 |
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Basic information
Public title
The safety and usefulness of Bariatric surgery(laparoscopic sleeve gastrectomy)
Acronym
The safety and usefulness of laparoscopic sleeve gastrectomy
Scientific Title
The safety and usefulness of Bariatric surgery(laparoscopic sleeve gastrectomy)
Scientific Title:Acronym
The safety and usefulness of laparoscopic sleeve gastrectomy
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to reduce the weight of obese patients with advanced gastrectomy shaped sleeve laparoscopic (laparoscopic sleeve gastrectomy) enforcement, an evaluation of the procedure and its therapeutic effect, to examine the safety and usefulness of this treatment .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Width reduction surgery (reduction of excess weight), changes in dietary intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
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
BMI>40, and have serious complications or with 40>BMI>35, or obese non-diabetic
With more than one complication caused by other bariatric patients to be invalid
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
| 19 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
BMI>40, and have serious complications or with 40>BMI>35, or obese non-diabetic
With more than one complication caused by other bariatric patients to be invalid
Key exclusion criteria
It is difficult to general anesthesia, patients with severe underlying disease and cardiorespiratory depression.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Shimada |
Organization
University of Tokushima
Division name
Surgery
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL
088-633-9277
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tokushima
Division name
Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
University of Tokushima
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 09 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 05 | Day |
Last modified on
| 2011 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007434
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
