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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024732
Receipt No. R000028459
Scientific Title Feasibility, safety and efficacy of laparoscopic sleeve gastrectomy for obese patients with BMI over 32.0 kg/m2: A prospective, non-randomized, single center study
Date of disclosure of the study information 2016/11/20
Last modified on 2019/11/10

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Basic information
Public title Feasibility, safety and efficacy of laparoscopic sleeve gastrectomy for obese patients with BMI over 32.0 kg/m2: A prospective, non-randomized, single center study
Acronym Laparoscopic sleeve gastrectomy for obese patients
Scientific Title Feasibility, safety and efficacy of laparoscopic sleeve gastrectomy for obese patients with BMI over 32.0 kg/m2: A prospective, non-randomized, single center study
Scientific Title:Acronym Laparoscopic sleeve gastrectomy for obese patients
Region
Japan

Condition
Condition Obesity
Classification by specialty
Endocrinology and Metabolism Gastrointestinal surgery Endocrine surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify safety and efficacy of laparoscopic sleeve gastrectomy for obese patients with BMI over 32.0 kg/m2
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The improvement rate of obesity-related metabolic disease at 1 year after surgery: glycosylated hemoglobin (HbA1c) < 7.0%, LDL cholesterol < 100 mg/dl and systolic blood pressure < 130 mmHg.
Key secondary outcomes Post-operative complications
Body weight, BMI, %EWL

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 1) Age 18 to 65 years
2) Written informed consent is obtained
3) Under the active care of a doctor for at least the 6 months prior to enrollment
4) BMI over 32.0 kg/m2
5) Obese patient with DM or more than one obesity-related metabolic disease
Key exclusion criteria 1) Cardiovascular event in the past 6 months or unstable ungina
2) Pulmonary embolus or thrombophlebitis in the past 6 months
3) Cancer of any kind unless documented to be disease-free for 5 years
4) Significant anemia or coagulopathy
5) Renal dysfunction: serum creatinine 2.0 mg/dl and over
6) Hepatic dysfunction: serum total bilirubin greater than 1.5 times the upper limit of normal, or alkaline phosphatase or ALT greater than twice the upper limit of normal. Chronic hepatitis B or C, cirrhosis
7) History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.
8) Gastric or duodenal ulcer in the past 6 months
9) History of intra-abdominal sepsis
10) Currently pregnant or nursing
11) Receiving steroids
12) Receiving immune suppressor
13) Patients with pulmonary disease and require continuous oxygen therapy
14) History of alcohol or drug dependency in the past 5 years
15) Patients with psychiatric or mental disorders
16) Exclusions may also be made at the discretion of the attending physician
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Hiramatsu
Organization Hamamatsu University School of Medicine
Division name Bariatric and metabolic surgery
Zip code 4313192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL 053-435-2279
Email hiramatu@hama-med.ac.jp

Public contact
Name of contact person
1st name Yoshihiro
Middle name
Last name Hiramatsu
Organization Hamamatsu University School of Medicine
Division name Bariatric and metabolic surgery
Zip code 4313192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL 053-435-2279
Homepage URL
Email hiramatu@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu 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 Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
Tel 053-435-2680
Email rinri@hama-med.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
2016 Year 11 Month 20 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
2016 Year 10 Month 12 Day
Date of IRB
2016 Year 11 Month 04 Day
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2020 Year 12 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
2016 Year 11 Month 07 Day
Last modified on
2019 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028459

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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