Evaluation of the Dietary Supplement Refill Bypass Administered Sublingually to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery Type Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Reduction of iron deficiency
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a scheduled bariatric surgery "gastric bypass",
- •Patient who performed a blood test before surgery,
- •Patient compliant.
排除标准
- •Allergy to components of the dietary supplement,
- •Pregnancy or breastfeeding,
- •Any biological abnormality considered by the investigator significant.
结局指标
主要结局
Reduction of iron deficiency
时间窗: Month 1, Month 3, Month 6, Month 12 after surgery
次要结局
- Measurement of Ferritin(Month 3, Month 6, Month 12 after surgery)
- Measurement of Hb1Ac(Month 3, Month 6, Month 12 after surgery)
- Satisfaction questionnaire(Month 1, Month 3, Month 6, Month 12 after surgery)
- Measurement of Vitamin B6(Month 3, Month 6, Month 12 after surgery)
- Measurement of Vitamin B1(Month 3, Month 6, Month 12 after surgery)
- Measurement of Vitamin B12(Month 3, Month 6, Month 12 after surgery)
- Measurement of Albumin(Month 3, Month 6, Month 12 after surgery)
- Measurement of Hemoglobin(Month 3, Month 6, Month 12 after surgery)
- Measurement of Vitamin B9(Month 3, Month 6, Month 12 after surgery)