Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy: Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- bone mass density
研究概览
简要总结
This study will examine the effect of providing a structured program of daily nutritional supplements for a 8 weeks of intervention prior to Sleeve Gastrectomy bariatric surgery on bone mass density status and formation of critical nutritional deficiencies years after the surgery.
详细描述
The present study hypothesis holds that providing an adequate nutritional supplements program prior to the surgery, combined with postoperative monitoring, will significantly lower the incidence of nutritional deficiencies in patients undergoing Sleeve Gastrectomy surgery, and will reduce complications arising from these pre-operative deficiencies.
The investigators plan to examine the effect of Vitamins supplementation prior to surgery on the status of postoperative deficiencies one year after the surgery. Evaluation of outcomes will be made based on the results of blood tests specified, and related tests of bone density.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for bariatric surgery
- •BMI over 35 kg / m 2 accompanying morbidity or BMI over 40 kg / m 2,
- •pre-operative evaluation standards with matching to carry sleeve gastrectomy surgery
- •Vitamin D deficiency prior to surgery
排除标准
- •patients who underwent bariatric surgery in the past
- •psychiatric or mentally contraindication for the procedure
- •lack of consent to follow-up
- •endocrine problem that affects the weight that is unbalanced.
- •Chronic kidney disease (CKD), nephrolithiasis
- •Hypercalcaemia
- •Hypercalciuria and renal stones nephrolithiasis
- •Pregnancy, breastfeeding
- •Using medications or disease condition known as affecting the status of calcium or bone metabolism 3 month prior to intervention
- •Taking any nutritional supplements 2 weeks before the study.
结局指标
主要结局
bone mass density
时间窗: 1 year
Status bone density one year after surgery will be measured by bone density test (DXA = X-ray dual energy absorptiometry) in units of g / cm2.
次要结局
- Parathyroid hormone (PTH) status after the surgery(1 year)
- Weight loss after the surgery(1 year)
- Vitamin D status after the surgery(1 year)
- Vitamin B12 status after the surgery(1 year)
- Iron status after the surgery(1 year)
- Folate status after the surgery(1 year)
研究者
Ram Elazary
Head bariatric surgeon Hadassah Ein Cerem Medical Center
Hadassah Medical Organization