UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the usefulness and safety of laparoscopic sleeve gastrectomy for advanced obesity cases
Title of the study (Brief title)	laparoscopic sleeve gastrectomy for advanced obesity cases
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	Evaluation of usefulness and safety of surgical treatment for highly obese patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative weight loss (reduction in excess weight)
Key secondary outcomes	complications

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients whose BMI is over 35. Patients whose BMI is over 32 with severe diabetes and/or other 2 co-morbidities related to obesity.
Key exclusion criteria	Secondary obesity patients Patients thought to be not suitable to this study
Target sample size	10

Research contact person
Name of lead principal investigator	Takayuki Nobuoka
Organization	Sapporo Medical University Hospital
Division name	Department of Surgery, Surgical Oncology and Science
Address	South 1,West 16, Chuo-ku
TEL	011-611-2111
Email	tnobu@sapmed.ac.jp

Public contact
Name of contact person	Takayuki Nobuoka
Organization	Sapporo Medical University Hospital
Division name	Department of Surgery, Surgical Oncology and Science
Address	South 1,West 16, Chuo-ku
TEL	011-611-2111
Homepage URL
Email	tnobu@sapmed.ac.jp

Sponsor
Institute	Department of Surgery, Surgical Oncology and Science, Sapporo Medical University Hospital
Institute
Department

Funding Source
Organization	Department of Surgery, Surgical Oncology and Science, Sapporo Medical University Hospital
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	2019 Year 09 Month 26 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 13 Day
Anticipated trial start date	2017 Year 10 Month 01 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	2017 Year 09 Month 26 Day
Last modified on	2017 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033496