UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034601 |
|---|---|
| Receipt number | R000039447 |
| Scientific Title | The usefulness of the sleeve gastrectomy with bypass in metabolic/bariatric surgery. |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2018/10/22 20:49:52 |
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Basic information
Public title
The usefulness of the sleeve gastrectomy with bypass in metabolic/bariatric surgery.
Acronym
The usefulness of the sleeve gastrectomy with bypass in metabolic/bariatric surgery.
Scientific Title
The usefulness of the sleeve gastrectomy with bypass in metabolic/bariatric surgery.
Scientific Title:Acronym
The usefulness of the sleeve gastrectomy with bypass in metabolic/bariatric surgery.
Region
| Japan |
Condition
Condition
Morbid obesity patients with DM
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness and safety of Laparoscopic Sleeve Gastrectomy / Duodeno-Jejunal Bypass: LSG / DJB
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of the incidence of CD-III in post operative 30 days.
Key secondary outcomes
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
Laparoscopic Sleeve Gastrectomy
/ Duodeno-Jejunal Bypass: LSG / DJB
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
Age:20-65
SEX:Both
BMI:over 35
ABCD score less 5
Informed consent
Key exclusion criteria
Mental disorder
Secondary obesity
Non effective case
Severe renal dysfunction
Severe liver dysfunction
Pregnant
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kozo Yoshikawa |
Organization
University of Tokushima
Division name
Department of digestive surgery
Zip code
Address
3-18-15 Kuramoto-Cho Tokushima
TEL
088-633-9276
yoshikawa.kozo@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kozo Yoshikawa |
Organization
University of Tokushima
Division name
Department of digestive surgery
Zip code
Address
3-18-15 Kuramoto-Cho Tokushima
TEL
088-633-9276
Homepage URL
yoshikawa.kozo@tokushima-u.ac.jp
Sponsor or person
Institute
University of Tokushima
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 01 | 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
| 2018 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 11 | 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
| 2018 | Year | 10 | Month | 22 | Day |
Last modified on
| 2018 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039447
