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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029370
Receipt No. 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 2019/02/09

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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
Middle name
Last name Hiramatsu Kazuhiro
Organization Toyohasi Municipal Hospital
Division name Department of general surgery
Zip code
Address 50 hakken-nish Aotake-Cho Toyohashi City Aichi Japan
TEL +81-532-33-6111
Email hiramatsu-kazuhiro@toyohashi-mh.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiramatsu Kazuhiro
Organization Toyohasi Municipal Hospital
Division name Department of general surgery
Zip code
Address 50 hakken-nish Aotake-Cho Toyohashi City Aichi Japan
TEL +81-532-33-6111
Homepage URL
Email hiramatsu-kazuhiro@toyohashi-mh.jp

Sponsor
Institute Toyohashi Municipal Hospital
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 01 Month 15 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 10 Month 01 Day
Last modified on
2019 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033565

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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