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| Name | Class |
|---|---|
| CEISO | INDUSTRY |
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This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes will be performed at 1 month, 3 months, 6 months and 9 months.
This observational study is non-interventional, it does not change the usual care of patients who underwent a bariatric surgery. Data collection will be carried out during routine visits planned in the post-operation usual follow-up. The blood tests are part of the patient's usual care for his bariatric surgery.
Surgeons will include patients for whom they have freely decided to use the dietary supplement Refill under the care of the treatment of obesity. The motivation of the patient and his commitment to the project is evaluated by the surgeon.
The main objective is to evaluate the efficacy of the dietary supplement Refill.
The primary endpoint is the reduction of iron deficiency.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Refill Bypass | Dietary Supplement | Dietary supplement |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of iron deficiency | Month 1, Month 3, Month 6, Month 12 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction questionnaire | Month 1, Month 3, Month 6, Month 12 after surgery | |
| Measurement of Ferritin | Month 3, Month 6, Month 12 after surgery | |
| Measurement of Vitamin B1 |
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Inclusion Criteria:
Exclusion Criteria:
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Obese patients who underwent bariatric surgery
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| Name | Affiliation | Role |
|---|---|---|
| Radwan KASSIR, Dr. | CHU St Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Nord Chu42 | Saint-Priest-en-Jarez | France |
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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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| Month 3, Month 6, Month 12 after surgery |
| Measurement of Vitamin B6 | Month 3, Month 6, Month 12 after surgery |
| Measurement of Vitamin B9 | Month 3, Month 6, Month 12 after surgery |
| Measurement of Vitamin B12 | Month 3, Month 6, Month 12 after surgery |
| Measurement of Hemoglobin | Month 3, Month 6, Month 12 after surgery |
| Measurement of Albumin | Month 3, Month 6, Month 12 after surgery |
| Measurement of Hb1Ac | Month 3, Month 6, Month 12 after surgery |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |