UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029370 |
|---|---|
| Receipt number | R000033565 |
| Scientific Title | Appraisal of security and feasibility of laparoscopic sleeve gastrectomy in bariatric surgery in single institution |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2021/10/06 13:15:10 |
* 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
Appraisal of security and feasibility of laparoscopic sleeve gastrectomy in bariatric surgery in single institution
Acronym
Appraisal of security and feasibility of laparoscopic sleeve gastrectomy in bariatric surgery
Scientific Title
Appraisal of security and feasibility of laparoscopic sleeve gastrectomy in bariatric surgery in single institution
Scientific Title:Acronym
Appraisal of security and feasibility of laparoscopic sleeve gastrectomy in bariatric surgery
Region
| Japan |
Condition
Condition
Highly obese patients with BMI> 35kg/m2 and one or more complications including diabetes mellitus, hypertension, dyslipidemia, liver dysfunction, sleep apnea syndrome etc. with BMI> 30 kg
Classification by specialty
| Endocrinology and Metabolism | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and effectiveness
of laparoscopic sleeve gastrectomy for bariatric surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the safety of laparoscopic
sleeve gastrectomy for bariatric surgery
Key secondary outcomes
To evaluate the effectiveness
of laparoscopic sleeve gastrectomy for 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
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Primary obese patient with age from 18 to 65 year old and neither significant improvement in weight loss nor complications associated with obesity is observed despite medical treatment for 6 months or more.
Furthermore, patients should be fulfilled one of the following conditions
1.weight loss as a primary purpose of surgery (Bariatric Surgery) is BMI 35kg/m2
or more.
2.for metabolic surgery as the main
purpose of treatment for complications
including at least one as follows,
diabetes, hypertension, dyslipidemia,
Key exclusion criteria
1) When mental illness with poor control is merged
2) In addition, patients who are deemed as inappropriate by researcher.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Hiramatsu |
Organization
Toyohasi Municipal Hospital
Division name
Department of general surgery
Zip code
441-8570
Address
50 hakken-nish Aotake-Cho Toyohashi City Aichi Japan
TEL
0532336111
kazuhirohiramatsumd@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Hiramatsu |
Organization
Toyohasi Municipal Hospital
Division name
Department of general surgery
Zip code
441-8570
Address
50 hakken-nish Aotake-Cho Toyohashi City Aichi Japan
TEL
0532336111
Homepage URL
https://www.municipal-hospital.toyohashi.aichi.jp/
kazuhirohiramatsumd@yahoo.co.jp
Sponsor or person
Institute
Toyohashi Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyohashi Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
supporting-office of IRB
Address
50 Hakken-Nishi Aotake-Cho Toyohashi Japan
Tel
0532336111
supporting-office@toyohashi-mh.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 | 12 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | 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 | 10 | Month | 01 | Day |
Last modified on
| 2021 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033565
