Pancreatic Resection, Malnutrition, and Readmission: Assessment and Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Readmission Rate
研究概览
简要总结
The Whipple procedure is associated with increased readmission rates for infection, pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop an evidence based perioperative nutrition plan to improve patient outcomes. The study has two specific aims including evaluation of feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a standard perioperative nutritional plan on primary outcome of readmission rate and secondary outcomes of readmission cause, length of stay for initial hospitalization and/or readmission, post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying), and nutritional status (PG-Subject Generated Assessment scores, BMI, albumin, pre-albumin, and method of oral intake). Categorical variables including readmission rate, readmission cause, post-surgical complications and nutritional status will be compared by chi-square test between intervention and control group. Length of stay for initial hospitalization and readmission will be compared by non parametric Wilcoxon test between two groups. Descriptive statistics will be used to describe the sample. There are no risks to the study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patients (>18 years of age)at Duke Cancer Center
- •Malignant pancreatic disease, undergoing surgical resection with pancreaticoduodenectomy (Whipple)
- •Able to read and speak English.
排除标准
- •Patients receiving preoperative enteral nutrition
- •Inability to tolerate preoperative oral intake
结局指标
主要结局
Readmission Rate
时间窗: Up to week 6
Evaluate the impact of a standard perioperative nutritional plan on primary outcome of readmission rate.
Feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple as measured by percentage of adherence to nutritional protocol
时间窗: Up to week 6
Evaluate the feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple by outcomes of: 1)admission rates, 2) admission causes 3)percentage of adherence to nutritional protocol 4) length of stay 5) reported symptoms (nausea, vomiting, diarrhea), 6) postsurgical complications 7) nutritional status preoperative visit between days 2 - 5 postoperatively, on the day of discharge, and at follow up visits at weeks 1, 3 and 6.
次要结局
- Post surgical complications(Up to week 6)
- Readmission cause(Up to week 6)
- Nutritional status(Up to week 6)
- Length of stay for initial hospitalization and/or readmission(Up to week 6)