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临床试验/NCT01130675
NCT01130675已完成3 期

Does Coffee Consumption Prevent or Shorten Postoperative Ileus After Colon Resection? A Prospective Randomized Clinical Trial

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2010年4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
44
试验地点
2
主要终点
Resolution of ileus

研究概览

简要总结

The purpose of this study is to determine if consuming an 8 ounce cup of coffee with breakfast and lunch is effective in preventing or reducing postoperative ileus.

详细描述

Recent evidence has shown that a multimodal rehabilitation program can accelerate recovery of GI function after colon resection. 8 A multicenter, randomized, placebo-controlled, double-blind, phase 3 trial demonstrated that Alvimopan, a peripherally acting mu-opioid receptor antagonist, appears to accelerate GI tract recovery by 1 day, and reduces postoperative ileus-related morbidity without compromising opioid analgesia. 9 Asao et al demonstrated that gum chewing can accelerate recovery of GI function, also by 1 day, after abdominal surgery. 10 Epidural anesthesia has been shown to shorten duration of POI, as well as improve pain control, decrease pulmonary complications, and quicken recovery times. However, it does not appear to reduce overall length of stay. 4 However, Neudecker et al. were unable to reproduce the results of previous trials evaluating the effect of thoracic epidural analgesia on duration of postoperative ileus following laparoscopic sigmoid resection. 11 Given conflicting data, no one single measure has been adopted for the prevention POI.

Recent evidence has shown that coffee may be a stimulant for the GI Tract. A small study of 16 healthy volunteers demonstrated that coffee appears to increase rectal tone thus implying an impact on defecation mechanics.12 Furthermore, several studies have demonstrated caffeinated coffee to be a stimulant of motor activity in the colon.13,14 Given its potential pro-motility properties in the GI tract, it seems reasonable to postulate that coffee, a commonly consumed product by the general public, may play a role in shortening and possibly preventing POI. This directly impacts overall patient satisfaction but will reduce length of stay and overall hospital costs.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective partial bowel resection with primary anastomosis for either cancer or benign disease.
  • Laparoscopy or laparotomy

排除标准

  • Total colectomy
  • Colostomy
  • Ileostomy
  • Reversal of a stoma or synchronous resection
  • Complete small or large bowel obstruction
  • Scheduled to receive other treatments or techniques to reduce ileus
  • epidural anesthetic tecniques
  • Nasogastric tube for any length of timein the post-op period.

结局指标

主要结局

Resolution of ileus

时间窗: a mean difference of 24 hours to be significant

Measured by hours to first flatus or bowel movement and tolerance of solid food.

次要结局

未报告次要终点

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Sponsor

研究点 (2)

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