NCT01084070已完成3 期
Randomized Clinical Trial of Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
Hospital General de Agudos "Dr. Cosme Argerich"1 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2010年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Postoperative Complications
研究概览
简要总结
The traditional postoperative care after abdominal surgery included the need of nasogastric tube, fasting until resumed bowel function and progressive reinstitution of oral intake from liquid to solid diet. Recent studies have shown no benefits of this traditional management over early oral feeding. Nevertheless, the researches in emergency surgery are scarce.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 14 years after abdominal emergency surgery.
排除标准
- •Lack of consensus of the patient
- •Concurrent extra-abdominal surgery
- •Short bowel or other clear indication of parenteral nutrition
- •Inability to feed orally (eg, decreased level of consciousness)
- •Interventional procedure
- •Esophageal surgery
- •Reoperations
- •Pancreatitis
结局指标
主要结局
Postoperative Complications
时间窗: At 30 days or at discharge
The rate of postoperative complications according with Clavien-Dindo classification, defined as "any deviation from the normal postoperative course".
次要结局
- Gastrointestinal leaks(At 30 days or at discharge)
- Time to resume bowel functions(At 30 days or at discharge)
- Oral diet intolerance(At 30 days or at discharge)
- Postoperative hospital stay(At 90 days)
研究者
Klappenbach Roberto
Investigator
Hospital General de Agudos "Dr. Cosme Argerich"
研究点 (1)
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