跳至主要内容
临床试验/NCT02260128
NCT02260128Unknown不适用

Effect of Chewing Gum on Postoperative Bowel Function Following Upper GI Tract Cancer Surgery

Michael Bau Mortensen1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
72
试验地点
1
主要终点
Time from surgery to first flatus

研究概览

简要总结

Every patient undergoing surgery in the abdomen will experience temporary paralysis of bowel function. This study evaluates whether chewing gum can reduce the bowel paralysis after surgery in patients undergoing either esophageal resection or whipples procedure. Half the study population will receive chewing gum while the other half will act as control.

详细描述

Every surgical procedure results in a temporary paralysis of bowel function. This condition is named postoperative ileus (POI) and it is characterized by absence of intestine motility, accumulation of gas and fluid inside the intestines and absence of flatus and defecation. It results in nausea, vomiting, abdominal distension, pain and lowered tolerance towards intake of fluid and solid foods. POI is the organism's reaction to the surgical trauma and it is most often the single most important factor determining the length of patient admission. Prolonged POI can also result in medical complications.

The length of POI following elective abdominal surgery is most often 3 to 6 days. Gradually during this period the intestines regain their normal behavioral pattern. The colon is the last segment to regain its motility which decides the patient's wellbeing. Therefore most investigations of POI measure time from surgery to first flatus or defecation.

The cause of POI is found in the surgical trauma. When the abdominal wall and the peritoneum are penetrated and the intestines exposed and handled, the immune system is activated. The immune system creates an inflammatory response that inhibits the local neural pathways in the intestines. The size of the immune response is related to the size of the surgical procedure and the length of POI. Together with the overall hormonal surgical stress response the inflammatory response creates a shift in the autonomous nervous system towards sympathetic domination. This further inhibits bowel activity.

The intake of food activates parasympathetic activity and promotes bowel activity. Early food intake following abdominal surgery, however, is often ill received by the patients hence the above mentioned symptoms of POI. The early food intake can also worsen complications following surgery such as anastomotic leakage. This is most pronounced with anastomoses on the esophagus and stomach. Therefore abstinence from food intake is often recommended in the immediate postoperative period.

Chewing of chewing gum following surgery can be perceived as placebo intake of food because it also activates the parasympathetic nervous system and under normal conditions the cephalic part of the digestion. Gum chewing does not, however, result in worsening of potential surgical complications and it is generally well tolerated by the patients. Postoperative gum chewing has been investigated and found effect full in the shape of reduced POI following colorectal surgery, abdominal surgery on the aorta, bladder surgery, and caesarian section.

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
是

入选标准

  • •Patients undergoing esophageal/cardial resection due to cancer and patients undergoing whipples procedure due to cancer.
  • •Macroradical resection must be accomplished.
  • •Informed consent given.

排除标准

  • •Patients WHO fail to follow the study regimen for more than 24 hours.
  • •Patients under the age of 18 years.
  • •Pregnant or beast feeding women.

研究组 & 干预措施

Gum chewing

Experimental

This intervention group will receive chewing gum four times daily following surgery. Each of which they are encouraged to chew for 30 minutes.

Gum chewing is terminated when one of the primary end points occurs.

干预措施: Chewing gum (Other)

Control group

No Intervention

This group will receive the normal postoperative treatment. Occurence of primary end points are registrered.

结局指标

主要结局

Time from surgery to first flatus

时间窗: 7 days

Time from surgery to first defecation

时间窗: 7 days

次要结局

未报告次要终点

研究者

发起方
Michael Bau Mortensen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Bau Mortensen

Professor

Odense University Hospital

研究点 (1)

Loading locations...

相似试验