Early Feeding vs 5-day Fasting After Distal Elective Bowel Anastomoses in Children. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Need to insert a NGT, beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay.
研究概览
简要总结
Purpose:
To determine the safety and efficacy of early enteral feeding after distal (ileum-colon) elective bowel anastomoses in children.
Methods:
Controlled randomized trial including all pediatric patients with distal elective bowel anastomosis, excluding non-elective and high risk patients. VARIABLES:
Demographic characteristics, operative time, anastomosis placement,
Follow up: Tolerability variables: beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay. Safety variables: mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and death. At the end of surgery were randomized to:
- Experimental group(EG): Early feeding group, after a 24 hours fasting period, with good abdominal conditions (once the post operative ileus had solved), oral fluids and diet was started.
- Control group (CG): obligatory 5-day fasting. Once the regular diet was tolerated, the patients were discharged. Statistics: Descriptive statistics for global description. Student's t test for quantitative variables and Chi square test for qualitative variables, a p-value less than 0.05 was considered statistically significant.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients between the ages of 1 month to 18 years old that required elective laparotomy with a distal elective bowel anastomosis (ileum and colon).
排除标准
- •Proximal and non elective anastomosis
- •High risk groups:
- •Upper gastrointestinal tract anastomosis (esophagus, gastric, duodenal or jejunal)
- •Bilious-digestive or rectal anastomosis
- •Immunosuppressed patients
- •Gastrostomy or any pre anastomotic derivation
- •Multiple anastomoses
- •Chronic intestinal obstruction
- •Patients who did not complete the minimum POP follow up of one month.
结局指标
主要结局
Need to insert a NGT, beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay.
时间窗: First 5 postoperative days
次要结局
- Mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and death(First 30 postoperative days)