UMIN-CTR Clinical Trial

Basic information
Public title	Safety and effectiveness of laparoscopic sleeve gastrectomy
Acronym	Safety and effectiveness of laparoscopic sleeve gastrectomy
Scientific Title	Safety and effectiveness of laparoscopic sleeve gastrectomy
Scientific Title:Acronym	Safety and effectiveness of laparoscopic sleeve gastrectomy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the result of surgical treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complication rate and % excess weight loss
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	Historical
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients who is more than 20 years old obtaining informed consent. 2. Patients with Diabetes mellitus, hypertention, hyperlipidemia 3. Patients who do not have sufficient weight loss and improvement of complications associated with obesity with medical treatments longer than 6 months 4. Performance status 0 or 1
Key exclusion criteria	1.Psychiatric patients who is difficult to participate in this study. 2. Dependence of drugs, alcohol, tobacco 3. Patients with taking immunosuppressive drugs 4. Patients with serious heart failure
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name KODERA
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	4668550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2233
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name TANAKA Middle name Last name Chie
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2249
Homepage URL
Email	chtanaka@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine
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	The Institutional Review Board of the Ethics Committee of Nagoya University School of Medicine
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel	052-744-2061
Email	ethics@med.nagoya-u.ac.jp

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	2017 Year 04 Month 01 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	10
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	No longer recruiting
Date of protocol fixation	2017 Year 04 Month 01 Day
Date of IRB	2017 Year 05 Month 10 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2023 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 17 Day
Last modified on	2020 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030093