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临床试验/NCT02469441
NCT02469441已完成不适用

Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery - a Prospective, Randomized Controlled Study - the COFFEE STUDY

Kantonsspital Baden1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
136
试验地点
1
主要终点
Time to first bowel movement

研究概览

简要总结

The aim of the study is to investigate if postoperative coffee intake decreases the time until first bowel movement in elective colorectal surgery with primary anastomosis.

详细描述

Postoperative ileus after colorectal surgery is a frequent problem which significantly prolongs hospital stay and increases perioperative costs. Postoperative therapeutic interventions vary significantly between different hospitals due to missing evidence-based guidelines. Coffee is a safe, cheap and simple agent without significant side effects which can positively influence the bowel function.

The aim of the investigators is to evaluate in an own study if coffee consumption has an influence on the duration of postoperative ileus.

The present trial is designed to evaluate if postoperative coffee intake decreases the time until first bowel movement in colorectal surgery with primary anastomosis. This study would be the second study which evaluates the described questions under randomized conditions.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Patients scheduled for elective laparoscopic or open colorectal surgery due to benign or malignant colorectal disease, which need a large bowel resection with primary anastomosis
  • Age equal or greater than 18 years
  • Patients that are able to give informed consent
  • Elective Surgery
  • Anastomosis above 6 cm from anal verge

排除标准

  • Participation in other studies
  • Additional small bowel anastomosis
  • Need for extended adhesiolysis
  • Need for a stoma (e.g. protective ileostomy)
  • Emergency operation with diffuse peritonitis or preexisting ileus
  • Preoperative radiation
  • Known hypersensitivity or allergy to coffee
  • Expected lack of compliance
  • Impaired mental state or language problems

结局指标

主要结局

Time to first bowel movement

时间窗: Follow-up per patient: 1 month postoperatively

Time to first bowel movement (time from the end of surgery until the first passage of stool recorded by nursing staff) as a marker for the termination of postoperative ileus.

次要结局

未报告次要终点

研究者

发起方
Kantonsspital Baden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gehrer Simone

Dr. med.

Kantonsspital Baden

研究点 (1)

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