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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046703
Receipt No. R000053277
Scientific Title Study on insufficient weight loss after sleeve gastrectomy: A multicentre retrospective study
Date of disclosure of the study information 2022/01/23
Last modified on 2022/01/23

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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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