UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029301 |
|---|---|
| Receipt number | R000033496 |
| Scientific Title | Investigation of the usefulness and safety of laparoscopic sleeve gastrectomy for advanced obesity cases |
| Date of disclosure of the study information | 2019/09/26 |
| Last modified on | 2017/09/26 21:15:53 |
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Basic information
Public title
Investigation of the usefulness and safety of laparoscopic sleeve gastrectomy for advanced obesity cases
Acronym
laparoscopic sleeve gastrectomy for advanced obesity cases
Scientific Title
Investigation of the usefulness and safety of laparoscopic sleeve gastrectomy for advanced obesity cases
Scientific Title:Acronym
laparoscopic sleeve gastrectomy for advanced obesity cases
Region
| Japan |
Condition
Condition
Morbid obesity
Classification by specialty
| Endocrinology and Metabolism | Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of usefulness and safety of surgical treatment for highly obese patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative weight loss (reduction in excess weight)
Key secondary outcomes
complications
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
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients whose BMI is over 35.
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 | |
| Middle name | |
| Last name | Takayuki Nobuoka |
Organization
Sapporo Medical University Hospital
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
Address
South 1,West 16, Chuo-ku
TEL
011-611-2111
tnobu@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Nobuoka |
Organization
Sapporo Medical University Hospital
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
Address
South 1,West 16, Chuo-ku
TEL
011-611-2111
Homepage URL
tnobu@sapmed.ac.jp
Sponsor or person
Institute
Department of Surgery, Surgical Oncology and Science, Sapporo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Surgical Oncology and Science, Sapporo Medical 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
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
| 2019 | Year | 09 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | 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
| 2017 | Year | 09 | Month | 26 | Day |
Last modified on
| 2017 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033496
