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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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St Priest En Jarez、フランス
- Hopital Nord Chu42
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Reduction of iron deficiency
時間枠：Month 1, Month 3, Month 6, Month 12 after surgery
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Month 1, Month 3, Month 6, Month 12 after surgery
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Satisfaction questionnaire
時間枠：Month 1, Month 3, Month 6, Month 12 after surgery
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Month 1, Month 3, Month 6, Month 12 after surgery
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Measurement of Ferritin
時間枠：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 Vitamin B1
時間枠：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 Vitamin B6
時間枠：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 Vitamin B9
時間枠：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 Vitamin B12
時間枠：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
時間枠：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
時間枠：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
時間枠：Month 3, Month 6, Month 12 after surgery
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Month 3, Month 6, Month 12 after surgery
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Refill Bypassの臨床試験
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Polyak, MaximilianHealth Resources and Services Administration (HRSA)完了
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Joslin Diabetes CenterBrigham and Women's Hospital完了