UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020292 |
|---|---|
| Receipt number | R000023432 |
| Scientific Title | Multicenter retrospective study to validate the safety and efficacy of laparoscopic sleeve gastrectomy and laparoscopic sleeve gastrectomy + duodeno-jejunal bypass for morbid obesity |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2017/12/25 20:23:31 |
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Basic information
Public title
Multicenter retrospective study to validate the safety and efficacy of laparoscopic sleeve gastrectomy and laparoscopic sleeve gastrectomy + duodeno-jejunal bypass for morbid obesity
Acronym
Multicenter retrospective study of laparoscopic sleeve gastrectomy and laparoscopic sleeve gastrectomy + duodeno-jejunal bypass
Scientific Title
Multicenter retrospective study to validate the safety and efficacy of laparoscopic sleeve gastrectomy and laparoscopic sleeve gastrectomy + duodeno-jejunal bypass for morbid obesity
Scientific Title:Acronym
Multicenter retrospective study of laparoscopic sleeve gastrectomy and laparoscopic sleeve gastrectomy + duodeno-jejunal bypass
Region
| Japan |
Condition
Condition
Morbid obesity
Classification by specialty
| Gastrointestinal surgery | Endocrine surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of Laparoscopic Sleeve Gastrectomy and Laparoscopic Sleeve Gastrectomy + Duodeno-Jejunal Bypass
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate safety
Confirm postoperative complications within 30 post operative days
Key secondary outcomes
To evaluate efficacy
Weight loss and HbA1c at 12months after surgery
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Morbid obesity patients who underwent LSG or LSG/DJB from January 2005 to December 2015, satisfying following conditions
1, BMI 35Kg / m2 or more at first medical examination
2, Age: 18-65 years of age
3, Gender: unquestioned
Key exclusion criteria
Patients determined to be inappropriate as a test subject by investigators
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Naitoh |
Organization
Tohoku University Hospital
Division name
Department of surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7205
naitot@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Tanaka |
Organization
Tohoku University Hospital
Division name
Department of surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7205
Homepage URL
n-tanaka@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Multicenter retrospective study
Including criteria
Morbid obesity patients who underwent LSG or LSG/DJB from January 2005 to December 2015, satisfying following conditions
1, BMI 35Kg / m2 or more, or BMI 32Kg / m2 or more complicated with DM
2, Age: 18-65 years of age
3, Gender: unquestioned
Management information
Registered date
| 2015 | Year | 12 | Month | 21 | Day |
Last modified on
| 2017 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023432
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
