UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009199 |
|---|---|
| Receipt number | R000010750 |
| Scientific Title | Laparoscopic sleeve gastrectomy with duodenojejunal bypass for patients with super morbid obesity or uncontrolable diabetes mellitus |
| Date of disclosure of the study information | 2012/10/31 |
| Last modified on | 2012/10/27 11:12:55 |
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Basic information
Public title
Laparoscopic sleeve gastrectomy with duodenojejunal bypass for patients with super morbid obesity or uncontrolable diabetes mellitus
Acronym
Laparoscopic sleeve gastrectomy with duodenojejunal bypass for obese patients
Scientific Title
Laparoscopic sleeve gastrectomy with duodenojejunal bypass for patients with super morbid obesity or uncontrolable diabetes mellitus
Scientific Title:Acronym
Laparoscopic sleeve gastrectomy with duodenojejunal bypass for obese patients
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Endocrinology and Metabolism | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether laparoscopic sleeve gastrectomy with duodenojejunal bypass is safe and effective in obese patients with super morbid obesity or uncontrolable diabetes mellitus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
safety and efficacy
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
Historical
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 with duodenojejunal bypass
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
Super morbid obesity and uncontrolable diabetes mellitus with poor insulin secretion
Key exclusion criteria
Heart or pulmonary failure
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Ohta |
Organization
Oita University Faculty of Medicine
Division name
Department of Surgery I
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Yufu, Oita 8795593, Japan
TEL
097-586-5843
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Ohta |
Organization
Oita University Faculty of Medicine
Division name
Department of Surgery I
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Yufu, Oita 8795593, Japan
TEL
097-586-5843
Homepage URL
ohta@oita-u.ac.jp
Sponsor or person
Institute
Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Oita University Faculty of Medicine
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
大分大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 31 | 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
| 2012 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 27 | Day |
Last modified on
| 2012 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010750
