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

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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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name