UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024732 |
|---|---|
| Receipt number | 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 | 2020/05/11 10:52:29 |
* 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
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
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
hiramatu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
5
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
| 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
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028459
