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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010300
Receipt No. R000005203
Scientific Title Laparoscopic surgery for morbid obesity
Date of disclosure of the study information 2013/03/22
Last modified on 2014/03/29

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Basic information
Public title Laparoscopic surgery for morbid obesity
Acronym Laparoscopic surgery for morbid obesity
Scientific Title Laparoscopic surgery for morbid obesity
Scientific Title:Acronym Laparoscopic surgery for morbid obesity
Region
Japan

Condition
Condition morbid obesity
Classification by specialty
Endocrinology and Metabolism Surgery in general Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 safety analysis of laparoscopic surgery for morbid obesity
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 LAGB
Interventions/Control_2 LSG
Interventions/Control_3 LRYGB
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 morbid obesity
resistant to nutritional therapy
Key exclusion criteria the parients who can not understand the surgical therapy.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahiro Matsubara
Organization Chiba University Graduate School of Medicine
Division name Frontier Surgery
Zip code
Address 1-8-1, Inohana, Chu-ou-ku, Chiba, Chiba 260-8670, Japan
TEL 043-226-2110
Email naohana718@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Hanari
Organization Chiba University
Division name Frontier Surgery
Zip code
Address 1-8-1, Inohana, Chu-ou-ku, Chiba, Chiba 260-8670, Japan
TEL 043-226-2110
Homepage URL
Email naohana718@faculty.chiba-u.jp

Sponsor
Institute Frontier Surgery, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Chiba University Hospital
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
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
2013 Year 03 Month 22 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
2009 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2010 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
2013 Year 03 Month 22 Day
Last modified on
2014 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005203

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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