UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter retrospective study to validate the safety and efficacy of laparoscopic sleeve gastrectomy and laparoscopic sleeve gastrectomy + duodeno-jejunal bypass for morbid obesity
Title of the study (Brief title)	Multicenter retrospective study of laparoscopic sleeve gastrectomy and laparoscopic sleeve gastrectomy + duodeno-jejunal bypass
Region	Japan

Condition
Condition	Morbid obesity
Classification by specialty	Gastrointestinal surgery Endocrine surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of Laparoscopic Sleeve Gastrectomy and Laparoscopic Sleeve Gastrectomy + Duodeno-Jejunal Bypass
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate safety Confirm postoperative complications within 30 post operative days
Key secondary outcomes	To evaluate efficacy Weight loss and HbA1c at 12months after surgery

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Morbid obesity patients who underwent LSG or LSG/DJB from January 2005 to December 2015, satisfying following conditions 1, BMI 35Kg / m2 or more at first medical examination 2, Age: 18-65 years of age 3, Gender: unquestioned
Key exclusion criteria	Patients determined to be inappropriate as a test subject by investigators
Target sample size	400

Research contact person
Name of lead principal investigator	Takeshi Naitoh
Organization	Tohoku University Hospital
Division name	Department of surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL	022-717-7205
Email	naitot@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Naoki Tanaka
Organization	Tohoku University Hospital
Division name	Department of surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL	022-717-7205
Homepage URL
Email	n-tanaka@surg1.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2016 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2017 Year 01 Month 01 Day
Date of closure to data entry	2017 Year 03 Month 30 Day
Date trial data considered complete	2017 Year 04 Month 30 Day
Date analysis concluded	2017 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Multicenter retrospective study Including criteria Morbid obesity patients who underwent LSG or LSG/DJB from January 2005 to December 2015, satisfying following conditions 1, BMI 35Kg / m2 or more, or BMI 32Kg / m2 or more complicated with DM 2, Age: 18-65 years of age 3, Gender: unquestioned

Management information
Registered date	2015 Year 12 Month 21 Day
Last modified on	2017 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023432