Evaluation of the Dietary Supplement Refill Bypass to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Dietary Supplement Refill Bypass Administered Sublingually to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery Type Gastric Bypass

Conditions
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Obesity, Bariatric Surgery

Intervention / Treatment
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* Dietary Supplement: Refill Bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a scheduled bariatric surgery gastric bypass, Patient who performed a blood test before surgery, Patient compliant. Exclusion Criteria: Allergy to components of the dietary supplement, Pregnancy or breastfeeding, Any biological abnormality considered by the investigator significant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Refill Bypass|Dietary supplement|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of iron deficiency |  | Month 1, Month 3, Month 6, Month 12 after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |