UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046703 |
|---|---|
| Receipt number | 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 19:30:53 |
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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
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
tsuyo@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Surgery, Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053277
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