Coffee After Pancreatic Surgery - a Randomised, Single Blinded, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- First Bowel Movement
研究概览
简要总结
Postoperative ileus is a common complication after major abdominal surgery. A positive effect of coffee to bowel movement has been described after colorectal and gynecologic interventions. The objective of this randomised controlled trial is to investigate whether the implementation of a fast track protocol with early coffee consumption accelerates the recovery of bowel function after pancreaticoduodenectomy.
详细描述
Postoperative ileus (POI) is a common disorder after major abdominal surgery, affecting up to 40% of patients undergoing laparotomy. POI is described as the time between surgery and the first passage of flatus and/or stool and tolerance of oral diet. It could be recognised as postoperative complication when is defined as two or more of nausea/vomiting, inability to tolerate oral diet over 24 h, absence of flatus over 24 h, abdominal distention and radiologic confirmation on or after day 4 postoperatively without prior resolution. Multimodal approaches have been described to treat POI; among them, the early consumption of coffee showed a substantial benefit after colorectal and gynecologic surgery. The objective of this randomised trial is to investigate whether early coffee consumption can accelerate the recovery of bowel function after open pancreaticoduodenectomy.
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
- Double (Participant, Care Provider)
盲法说明
Participants and staff were masked about the type of coffee administrated (standard coffee versus caffeine-free coffee). Masking about administration of hot water is not feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective open pancreaticoduodenectomy
- •Age ≥ 18 years
- •American Society Anesthesiologists (ASA) score ≤ 3
- •Ability of the subject to understand aims and clinical consequences of the trial
- •Written informed consent
排除标准
- •American Society Anesthesiologists (ASA) score ≥ 4
- •Need for early postoperative Intensive Care Unit care
- •Need for naso-gastric tube on postoperative day one
- •Intolerance to coffee
- •Refuse to assume coffee
- •Pregnancy
- •Surgical procedures performed different from pancreaticoduodenectomy
- •Impaired mental status or language problems
研究组 & 干预措施
standard coffee
Hot standard coffee with caffeine (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).
干预措施: Standard coffee (Dietary Supplement)
caffeine-free coffee
Hot caffeine-free coffee (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).
干预措施: Caffeine-free coffee (Dietary Supplement)
water
Hot water (one 30 mL espresso cup twice a day, from postoperative day one to first bowel movement or postoperative day three).
干预措施: Drinking water (Dietary Supplement)
结局指标
主要结局
First Bowel Movement
时间窗: 96 hours.
Time to first bowel movement (expressed by hours from the time of surgical procedure ending).
次要结局
- First Flatus(96 hours)
- Tolerance to solid food(96 hours)
- Length of stay(90 days)