Immunonutrition and Enhanced Recovery After Surgery Protocols in Gynecologic Oncology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Perioperative infections
研究概览
简要总结
A patient with oncological pathology of any type because of impaired digestion and nutrient absorption, decreased intake, and increased nutrition requirements has an increased risk of malnutrition and moderate to severe weight loss.In the present study the investigators will evaluate the impact of perioperative immunonutrition supplementation on the postoperative outcomes.
详细描述
Malnutrition has a major effect not only on the postoperative course of cancer surgery but can also complicate or even limit administration or compromise the effectiveness of other treatments such as chemotherapy or radiotherapy in the perioperative period. Immunonutrition is a type of artificial nutrition based on the use of some types of macro- or micronutrients.The purpose of this review was to evaluate the use, indications, and effects of these formulas in oncologic surgical patients in real time and to identify the types of patients who can benefit from enteral immunonutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with any gynaecologic malignancy enrolled in surgical list of our institute
- •must be able to consume oral supplements.
排除标准
- •women that are not able to follow ERAS protocol due to medical reasons
- •patients with severe disease that cannot compromise with protocol
结局指标
主要结局
Perioperative infections
时间窗: Postoperatively (30 days)
We will notice possible surgical site infections,respiratory inflammations etc and calculate inflammatory markers and the concentration of white blood cells
Duration of hospitalization
时间窗: Until discharge from hospital
From date of hospitalization until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.
次要结局
- Postoperative mobilization(Until first day of mobilization)
- Postoperative morbidity (other than infectious)(30 days)
- Recurrence rates(3 years follow-up)
- Overall survival(3 years follow-up)
研究者
Nikolaos Thomakos
Associate Professor of Obstetrics and Gynecology
National and Kapodistrian University of Athens