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The goal of this observational study is to evaluate whether preoperative fat-free mass predicts post-operative weight loss in patients undergoing Roux-En-Y gastric bypass. The primary objective of this study is to evaluate whether preoperative fat-free mass predicts weight loss in the two years following RYGB.
The investigators will collect the following data, assessed as part of routine follow-up:
Quality of life: quality of life by the "Bariatric Analysis and Reporting Outcome (BAROS) questionnaire", symptoms of dumping syndrome by the "Sigstad diagnostic score system" Birthdate, birthweight and term of their children
This study is prospective but the investigators will also use the retrospective data of the patients who underwent bariatric surgery before the acceptance of the study, with their informed consent.
The investigators will collect the following data, assessed as part of routine follow-up:
Preoperatively:
These assessments will be repeated after surgery at the frequency indicated below:
Study sample calculation:
The investigators hypothesized, in a conservative way and based on available litterature, that the patients will decrease their lean mass by 5±10 kg within 2 years after RYGB. A sample size of 32 achieves 90% power to detect a mean of paired differences of 5 kg with an estimated standard deviation of paired differences of 10.0 and with a significance level (alpha) of 0.050 using a two-sided paired t-test.
The investigators plan to evaluate whether preoperative FFM (independent variable) predicts weight loss (dependent variable) while adjusting for age, sex, preoperative BMI category (35-40, 40-50, > 50), and FM, physical activity. This corresponds to 6 adjustment variables altogether, or 3 supplemental variables. According to the rule of Harrel that stipulates at least 10 observations per independent variables, the investigators need at least 70 participants (10*(1+6)) to perform these adjustments.
Considering a drop-out rate of 30% at 2 years, the investigators will need a sample size of: 70+30% = 91 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with scheduled RYGB at the Geneva University Hospitals | Morbidly obese patients scheduled for Roux-en-Y gastric bypass |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between Fat-free mass (FFM) and weight loss following RYGB | FFM and lean body mass measurement using BIA and DXA, respectively | 2 years |
| Evolution of body composition in the two years after bariatric surgery | Measurments of body composition by dual energy X-ray absorptiometry before gastric bypass and yearly after gastric bypass | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with scheduled gastric bypass at the Geneva University Hospitals (HUG)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurence Genton, MD | Contact | 0041 79 553 34 84 | laurence.genton@hug.ch | |
| Laure Wilmart-Beck | Contact | 0041 22 372 93 49 | laure.wilmart@hug.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Recruiting | Geneva | Canton of Geneva | 1205 | Switzerland |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Blood biobank and gastric and intestinal tissue biobank
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |