UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025616 |
|---|---|
| Receipt number | R000029203 |
| Scientific Title | The validation study of the efficacy of surgical and endoscopic procedures for adiposity and related comorbidity. |
| Date of disclosure of the study information | 2017/01/23 |
| Last modified on | 2019/09/11 10:08:52 |
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Basic information
Public title
The validation study of the efficacy of surgical and endoscopic procedures for adiposity and related comorbidity.
Acronym
The validation study of the efficacy of surgical and endoscopic procedures for adiposity and related comorbidity.
Scientific Title
The validation study of the efficacy of surgical and endoscopic procedures for adiposity and related comorbidity.
Scientific Title:Acronym
The validation study of the efficacy of surgical and endoscopic procedures for adiposity and related comorbidity.
Region
| Japan |
Condition
Condition
Adiposity and related comorbidity.
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validate a weight-loss-effect of bariatric surgery and endoscopic intragastric balloon placement for obese patients that are resistant to medical therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Absolute weight loss and excess-weight loss late.
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
Initially, all patients undergo are performed endoscopic intragastric balloon placement. After 6 moths from performing endoscopic intragastric balloon placement, patients that meet the following inclusion criteria will be performed bariatric surgery (ex. Laparoscopic Adjustable Gastric Banding, Laparoscopic Roux en Y gastric bypass and 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Body Mass Index > 35
2. Existence of disability in daily life.
3. Resistant to the medical therapy.
4. Have an ability to understand this trial and strong preference to enroll in this trial.
- Inclusion criteria for bariatric surgery -
After 6 moths from performing endoscopic intragastric balloon placement, patients that meet 1. and 2.
Key exclusion criteria
1) Poor response to the previous medical therapy because of the patients' poor compliance.
2) Unwilling to undergo surgery.
3) Obese due to psychiatric disorders.
4) Have cosmetic purpose to enroll in this trial.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
TEL
03-3353-1211
hkawakubo@z3.keio.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
TEL
03-3353-1211
Homepage URL
hkawakubo@z3.keio.jp
Sponsor or person
Institute
Department of Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Keio University School of Medicine
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
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2017 | Year | 01 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2009 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2009 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 11 | Day |
Last modified on
| 2019 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029203
