UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005845 |
|---|---|
| Receipt number | R000006907 |
| Scientific Title | Evaluation of utility of the bariatric surgery for morbidly obese patients. |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2020/06/04 16:13:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of utility of the bariatric surgery for morbidly obese patients.
Acronym
Evaluation of utility of the bariatric surgery for morbidly obese patients.
Scientific Title
Evaluation of utility of the bariatric surgery for morbidly obese patients.
Scientific Title:Acronym
Evaluation of utility of the bariatric surgery for morbidly obese patients.
Region
| Japan |
Condition
Condition
Morbid obesity
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of effects of the bariatric surgery on improvement of patients' QOL and diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL improvement of bariatric surgery
Key secondary outcomes
Improvement of diabetes of bariatric surgery
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
Bariatric surgery
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
Patients whose BMI is over 37.
Patients whose BMI is over 32 with severe diabetes and/or other 2 co-morbidities related to obesity.
Key exclusion criteria
Secondary obesity patients
Patients thought to be not suitable to this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Tanaka |
Organization
Tohoku University Hospital
Division name
Department of surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
n-tanaka@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Tanaka |
Organization
Tohoku University Hospital
Division name
Department of surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
Homepage URL
n-tanaka@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Department of surgery, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of surgery, Tohoku University Hospital
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
Institutional Review Board of Tohoku University Hospital
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.ac.jp
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 | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | 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 | 06 | Month | 24 | Day |
Last modified on
| 2020 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006907
