UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006282
Receipt No. R000007434
Scientific Title The safety and usefulness of Bariatric surgery(laparoscopic sleeve gastrectomy)
Date of disclosure of the study information 2011/09/16
Last modified on 2011/09/05

* 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 The safety and usefulness of Bariatric surgery(laparoscopic sleeve gastrectomy)
Acronym The safety and usefulness of laparoscopic sleeve gastrectomy
Scientific Title The safety and usefulness of Bariatric surgery(laparoscopic sleeve gastrectomy)
Scientific Title:Acronym The safety and usefulness of laparoscopic sleeve gastrectomy
Region
Japan

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

Objectives
Narrative objectives1 We aim to reduce the weight of obese patients with advanced gastrectomy shaped sleeve laparoscopic (laparoscopic sleeve gastrectomy) enforcement, an evaluation of the procedure and its therapeutic effect, to examine the safety and usefulness of this treatment .
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Width reduction surgery (reduction of excess weight), changes in dietary intake
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization 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 BMI>40, and have serious complications or with 40>BMI>35, or obese non-diabetic
With more than one complication caused by other bariatric patients to be invalid
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
19 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria BMI>40, and have serious complications or with 40>BMI>35, or obese non-diabetic
With more than one complication caused by other bariatric patients to be invalid
Key exclusion criteria It is difficult to general anesthesia, patients with severe underlying disease and cardiorespiratory depression.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuo Shimada
Organization University of Tokushima
Division name Surgery
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL 088-633-9277
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Tokushima
Division name Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute University of Tokushima
Institute
Department

Funding Source
Organization University of Tokushima
Organization
Division
Category of Funding Organization
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
2011 Year 09 Month 16 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 Preinitiation
Date of protocol fixation
2011 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 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
2011 Year 09 Month 05 Day
Last modified on
2011 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007434

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.