Comparison of enhanced recovery after surgery versus conventional approach in gastric cancer - A randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Post operative hospital stay.
研究概览
简要总结
Gastric cancer is the fifth most common malignancy in the world andthird leading cause of cancer death in both sexes worldwide. A gastrectomywith lymphadenectomy is the mainstay of treatment and perioperativechemotherapy or chemoradiotherapy is administered in patients with advanceddisease. Gastric cancer was found to be the second most common cause of deathamong all fatal cancers in both sexes aged 30-69 years in India.
To minimize postoperative complications, the patients are kept fastingfrom the night before surgery till variable periods after that, the bowel ismechanically prepared, the patients are put on prolonged nasogatricdecompression, abdominal drains are put in for early detection of anastomoticleakage, many of these being conventional than being objectively of benefit.
Enhanced recovery after surgery (ERAS) is an evidence basedmultidisciplinary perioperative and postoperative care program, has droppedmany of the conventional approaches to get additional improvements in outcomessuch as decreased hospital stay, hospital cost without any increase in postoperativecomplications. This approach has been successfully carried out around theworld for colorectal surgeries. ERAS has successfully been tried in patientswith gastric cancer but the series have been small. In patients withgastric cancer, poor nutritional status pre operatively is common which mayinterfere with healing and post operative outcome. Hence this study has beenplanned to study the efficacy of ERAS protocol in such patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Histologically confirmed adenocarcinoma of stomach for which surgery is expected.
- •b) Patient age more than 18 years c) Accepting solids or at least oral liquids d) Eastern Cooperative Oncology Group performance status of 0, 1 or 2 e) American Society of Anesthesiologists score of I or II f) No contraindication of epidural anesthesia g) Written informed consent.
排除标准
- •a) Patients with uncontrolled diabetes or who needed the administration of insulin b) Pregnancy c) Involvement of duodenum.
结局指标
主要结局
Post operative hospital stay.
时间窗: The patient will be assessed on post operative days 1,2,3,4,5,6,7,8,9,10 and further unless patient meets the discharge criteria.
次要结局
- Incidence of complications such as anastomotic leak, bowel obstruction, pneumonia, surgical site infection, mortality, reoperation and readmission(30 days)