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临床试验/NCT03143621
NCT03143621已完成不适用

The Effect of Coffee Consumption on Return to Bowel Function After Small Bowel Resection

Mount Carmel Health System1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2017年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
1
主要终点
Time to removal of nasogastric tube

研究概览

简要总结

Post-operative ileus ("post-op ileus") is a condition which can occur after surgery. This means that the bowels stop working correctly and food and liquids will not pass through in the normal manner. Post-op ileus can be uncomfortable and require a longer hospital stay until the bowels begin to function correctly again. Currently there are no effective methods for preventing post-op ileus. Some studies suggest there is a benefit from drinking coffee following colon or gynecological cancer surgeries with very little risk. However, the effects of coffee following small bowel surgery have not been studied. This randomized, controlled trial will compare the outcomes of patients who receive coffee during their hospital stay after small bowel surgery to similar patients who receive warm water. About 60 patients will be in each group. The main outcomes are time until the nasogastric tube is removed and length of hospital stay.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Patients will not be told what group they are assigned to, however, complete masking will be difficult to achieve. The patient's treatment assignment is part of the medical record.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing small bowel resection. Can be elective, urgent or emergent.

排除标准

  • •Patient with atrial fibrillation who is considered a non-coffee drinker (drinks coffee less than 3 days per week over the last 4 weeks)
  • •Patients undergoing colon resection without removal of any portion of small bowel.

研究组 & 干预措施

Coffee

Experimental

100 cc's of coffee administered three times per day until return to bowel function has been established.

干预措施: Coffee (Dietary Supplement)

Water

Placebo Comparator

100 cc's of warm water administered three times per day until return to bowel function has been established.

干预措施: Water (Other)

结局指标

主要结局

Time to removal of nasogastric tube

时间窗: From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)

Time at placement to Time at removal through study completion

次要结局

  • Time to return of bowel function(From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks))
  • Length of Stay(From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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