UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026196 |
|---|---|
| Receipt number | R000030093 |
| Scientific Title | Safety and effectiveness of laparoscopic sleeve gastrectomy |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/06/10 15:12:31 |
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Basic information
Public title
Safety and effectiveness of laparoscopic sleeve gastrectomy
Acronym
Safety and effectiveness of laparoscopic sleeve gastrectomy
Scientific Title
Safety and effectiveness of laparoscopic sleeve gastrectomy
Scientific Title:Acronym
Safety and effectiveness of laparoscopic sleeve gastrectomy
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the result of surgical treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complication rate and % excess weight loss
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
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who is more than 20 years old obtaining informed consent.
2. Patients with Diabetes mellitus, hypertention, hyperlipidemia
3. Patients who do not have sufficient weight loss and improvement of complications associated with obesity with medical treatments longer than 6 months
4. Performance status 0 or 1
Key exclusion criteria
1.Psychiatric patients who is difficult to participate in this study.
2. Dependence of drugs, alcohol, tobacco
3. Patients with taking immunosuppressive drugs
4. Patients with serious heart failure
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | KODERA |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2233
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | TANAKA |
| Middle name | |
| Last name | Chie |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2249
Homepage URL
chtanaka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate 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
The Institutional Review Board of the Ethics Committee of Nagoya University School of Medicine
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-744-2061
ethics@med.nagoya-u.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 | 04 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | 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 | 02 | Month | 17 | Day |
Last modified on
| 2020 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030093
