UMIN-CTR Clinical Trial

Basic information
Public title	Study on insufficient weight loss after sleeve gastrectomy: A multicentre retrospective study
Acronym	Study on insufficient weight loss after sleeve gastrectomy
Scientific Title	Study on insufficient weight loss after sleeve gastrectomy: A multicentre retrospective study
Scientific Title:Acronym	Study on insufficient weight loss after sleeve gastrectomy
Region	Japan

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

Objectives
Narrative objectives1	To clarify the factors that cause insufficient weight loss after sleeve gastrectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Weight metrics at 1, 2, 3, 4, and 5 years after sleeve gastrectomy Exercise and snack habits, nutrition, frequency of patient educations (preoperative, 1/3/6 months, and 1 year after surgery)
Key secondary outcomes

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	Patients with obesity who underwent sleeve gastrectomy (LSG) at five institutions: Yotsuya Medical Cube, Tohoku University Hospital, Toho University Sakura Medical Center, Kansai Medical University Hospital, and Shiga University of Medical Science Hospital from January 1, 2011 to December 31, 2015, those who have passed 1 year after surgery
Key exclusion criteria	A person who has been offered to cancel the use of information in this research by the person or his / her substitute. Not the first surgery for obesity Those who are judged by the doctor in charge to be unsuitable for the examination
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Yamaguchi
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Otsu-city, Seta, Tsukinowa-cho
TEL	+81775482238
Email	tsuyo@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Tsuyoshi Middle name Last name Yamaguchi
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Otsu-city, Seta, Tsukinowa-cho
TEL	+81775482238
Homepage URL
Email	tsuyo@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Surgery, Shiga University of Medical Science
Institute
Department

Funding Source
Organization	JSPS KAKENHI Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shiga University of Medical Science Research Ethics Committee
Address	Otsu-city, Seta, Tsukinowa-cho
Tel	0775483576
Email	hqrec@belle.shiga-med.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	2022 Year 01 Month 23 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	Enrolling by invitation
Date of protocol fixation	2021 Year 09 Month 21 Day
Date of IRB	2021 Year 09 Month 27 Day
Anticipated trial start date	2021 Year 09 Month 28 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Age, gender, height, weight (at first visit and before surgery), duration of obesity, comorbidity (presence / absence, duration) Information on postoperative outcome, lifestyle, and patient education: a. Weight metrics at 1/3/6 months and 1/2/3/4/5 years after surgery, follow-up rate at each time b. Presence / absence and frequency of snacks and exercise before and 1/3/6 months and 1 year after surgery c. Nutritional evaluation of dietary content before and 1/3/6 months, and 1 year after surgery (total calorie intake per day, protein intake, frequency of drinking, etc.) d. Types and frequency of patient education before, 1/3/6 months, and 1 year after surgery e. Shape of residual stomach within 3 days after surgery (4 classifications by oral contrast examination) f. GERD evaluation (Los Angeles: LA classification), presence or absence of vomiting and other symptoms before and 1 year after surgery g. Information on complications of obesity-related comobidities before and 1/2/3/4/5 years after surgery: hypertension (presence / absence and medication status), type 2 diabetes (presence / absence and medication status), dyslipidemia (presence / absence and medication status) presence / absence), sleep apnea syndrome (presence / absence), orthopedic disease (presence / absence), mental illness (presence / absence) h. Additional information on preoperative and postoperative 1/2/3/4/5 years of type 2 diabetes: HbA1c (NGSP), insulin, C-peptide levels i. Presence or absence of perioperative complications (Clavien-Dindo classification Grade III or higher) j. Whether or not revision surgery was performed or considered, and timing and type of revision performed k. Minimum postoperative body weight and the time after surgery

Management information
Registered date	2022 Year 01 Month 23 Day
Last modified on	2022 Year 01 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053277

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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