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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | obesity | |
Classification by specialty |
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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 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |