High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Complications
研究概览
简要总结
Study investigators aim to assess the effect of providing high-protein nutritional supplementation before and after surgery
详细描述
Pancreaticoduodenectomy (PD) is a complex and morbid operation that is associated with many potential complications. Many people undergoing PD are malnourished due to their underlying medical condition or difficulties eating in the face of abdominal pain or obstruction from pancreatic disease. This study aims to assess the effect of high-protein dietary supplementation in improving perioperative nutrition and decreasing complications. We will randomize PD patients to an experimental arm in which they take a nutritional, high-protein supplement for 2 weeks before and after surgery, or to a control arm, where they will take a standard postoperative diet without supplementation. Outcomes and nutritional parameters will be examined after they complete the supplements.
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
- None
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
- •Patients undergoing pancreaticoduodenectomy
- •Patients aged 18 years and older
- •Patients able to provide written informed consent
- •Patients able to understand and comply with study guidelines
- •Patients able to tolerate oral intake
- •Patients who are malnourished or at risk of malnutrition as defined by a score less than 12 on the Mini-Nutritional Assessment
排除标准
- •Patients with a milk protein allergy
- •Patients with a vegan diet
- •Patients dependent on artificial enteral feeding
- •Patients with end-stage renal disease undergoing dialysis
- •Patients who are pregnant
- •Patients with ongoing eating disorder or condition precluding oral intake
- •Patients who are scheduled for pancreaticoduodenectomy but are unable to receive this surgery
结局指标
主要结局
Complications
时间窗: 30 days
All complications within 30 days of surgery
次要结局
- Overall Survival(6 months)
- Prealbumin level(30 days)