UMIN-CTR Clinical Trial

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
Email	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/
Email	kazuhirohiramatsumd@yahoo.co.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	supporting-office of IRB
Address	50 Hakken-Nishi Aotake-Cho Toyohashi Japan
Tel	0532336111
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033565