Perioperative Immunonutrition for Patients Undergoing Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Baseline wound infection rates
研究概览
简要总结
Patients with peritoneal disease commonly present with symptoms of abdominal distension and subacute intestinal obstruction. This results in poor oral intake leading to these patients often presenting in a malnourished state.
CRS and HIPEC can potential provide improve survival for these patients, however can be a hazardous procedure, involving multi-organ resections. The risk is especially high in poorly nourished patients.
The study investigators hypothesize that perioperative immunonutrition can reduce wound infections and length of hospital stay, and improve perioperative outcomes. To the investigators' knowledge, it has not been evaluated in patients undergoing CRS and HIPEC.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigators and the clinical team which manages the patient, will be blinded.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients planned for CRS and HIPEC, with sufficient time (5 to 7 days) prior to surgery for start of nutritional supplements are eligible
- •All patients must be able to provide informed consent
- •There are no restrictions to use of contraception
排除标准
- •Patients who are not able to provide informed consent will be excluded.
- •Patients with a diagnosis of diabetes mellitus will be excluded.
- •Patients not fit for surgery or those who undergo surgery under emergency situations will be excluded.
- •Patients who have intestinal obstruction and not able to consume the nutritional supplements orally will be excluded.
研究组 & 干预措施
Oral IMPACT
Perioperative immunonutrition will commence 5-7 days prior to surgery, and will continue for 5-7 days post-surgery, as soon as the patient is able to consume full feeds as instructed by his/her primary physician.
The recommended dose for IMPACT immunotherapy is one packet, to be taken three times a day.
干预措施: IMPACT immunotherapy (Dietary Supplement)
Standard Nutrition (ENSURE)
Standard nutritional supplementation will commence 5-7 days prior to surgery, and will continue for 5-7 days post-surgery, as soon as the patient is able to consume full feeds as instructed by his/her primary physician.
干预措施: ENSURE (Dietary Supplement)
结局指标
主要结局
Baseline wound infection rates
时间窗: From date of surgery to date that wound is healed, up to 30 days from surgery
次要结局
- Peri-operative complications(Within 30 days from surgery)
- Length of stay(100 days)