Evaluation of the Dietary Supplement Refill Bypass to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery (Refill)
Evaluation of the Dietary Supplement Refill Bypass Administered Sublingually to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery Type Gastric Bypass
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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St Priest En Jarez, Frankrig
- Hopital Nord Chu42
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Reduction of iron deficiency
Tidsramme: Month 1, Month 3, Month 6, Month 12 after surgery
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Month 1, Month 3, Month 6, Month 12 after surgery
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Satisfaction questionnaire
Tidsramme: Month 1, Month 3, Month 6, Month 12 after surgery
|
Month 1, Month 3, Month 6, Month 12 after surgery
|
|
Measurement of Ferritin
Tidsramme: Month 3, Month 6, Month 12 after surgery
|
Month 3, Month 6, Month 12 after surgery
|
|
Measurement of Vitamin B1
Tidsramme: Month 3, Month 6, Month 12 after surgery
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Month 3, Month 6, Month 12 after surgery
|
|
Measurement of Vitamin B6
Tidsramme: Month 3, Month 6, Month 12 after surgery
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Month 3, Month 6, Month 12 after surgery
|
|
Measurement of Vitamin B9
Tidsramme: Month 3, Month 6, Month 12 after surgery
|
Month 3, Month 6, Month 12 after surgery
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Measurement of Vitamin B12
Tidsramme: Month 3, Month 6, Month 12 after surgery
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Month 3, Month 6, Month 12 after surgery
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Measurement of Hemoglobin
Tidsramme: Month 3, Month 6, Month 12 after surgery
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Month 3, Month 6, Month 12 after surgery
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Measurement of Albumin
Tidsramme: Month 3, Month 6, Month 12 after surgery
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Month 3, Month 6, Month 12 after surgery
|
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Measurement of Hb1Ac
Tidsramme: Month 3, Month 6, Month 12 after surgery
|
Month 3, Month 6, Month 12 after surgery
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Radwan KASSIR, Dr., CHU St Etienne
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Refill
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