UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The usefulness of the sleeve gastrectomy with bypass in metabolic/bariatric surgery.
Title of the study (Brief title)	The usefulness of the sleeve gastrectomy with bypass in metabolic/bariatric surgery.
Region	Japan

Condition
Condition	Morbid obesity patients with DM
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the usefulness and safety of Laparoscopic Sleeve Gastrectomy / Duodeno-Jejunal Bypass: LSG / DJB
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of the incidence of CD-III in post operative 30 days.
Key secondary outcomes

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 / Duodeno-Jejunal Bypass: LSG / DJB
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Age:20-65 SEX:Both BMI:over 35 ABCD score less 5 Informed consent
Key exclusion criteria	Mental disorder Secondary obesity Non effective case Severe renal dysfunction Severe liver dysfunction Pregnant
Target sample size	7

Research contact person
Name of lead principal investigator	Kozo Yoshikawa
Organization	University of Tokushima
Division name	Department of digestive surgery
Address	3-18-15 Kuramoto-Cho Tokushima
TEL	088-633-9276
Email	yoshikawa.kozo@tokushima-u.ac.jp

Public contact
Name of contact person	Kozo Yoshikawa
Organization	University of Tokushima
Division name	Department of digestive surgery
Address	3-18-15 Kuramoto-Cho Tokushima
TEL	088-633-9276
Homepage URL
Email	yoshikawa.kozo@tokushima-u.ac.jp

Sponsor
Institute	University of Tokushima
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 12 Month 11 Day
Anticipated trial start date	2018 Year 12 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 22 Day
Last modified on	2018 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039447