跳至主要内容
临床试验/NCT00879294
NCT00879294撤回不适用

The Effect of Gum Chewing on Postoperative Ileus

Wake Forest University1 个研究点 分布在 1 个国家开始时间: 2009年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Time to resolution of post-operative ileus.

研究概览

简要总结

The purpose of this study is to see if chewing gum after surgery for perforated appendicitis will shorten the time of intestinal dysfunction.

详细描述

After operations for a ruptured appendix, children are usually not allowed to eat or drink anything. This is because the infection inside the abdomen and the manipulation of the intestines during the operation cause the bowels to stop their normal movement. The resulting lack of bowel function is called an "ileus". When this occurs, intestinal secretions and anything taken in by mouth can become backed up, causing bloating, abdominal pain, nausea and vomiting. Children are not allowed to eat or drink anything during this time and require fluid hydration through an IV or even nutrition through an IV. This ileus usually lasts an average of 4-5 days, and can sometimes delay the discharge of children who are otherwise ready to go. The purpose of this research study is to determine if simple things, like gum chewing or anti-motion sickness bracelets can help speed the time it takes for the bowels to begin working after an operation for a ruptured appendix. Because the gum is not swallowed, it does not have the same effects as eating and drinking would on someone with an ileus. The same is true for the anti-motion sickness bracelets. Yet, it is thought that the chewing action from gum may stimulate the intestines into thinking that food is on the way and cause them to start working sooner than they otherwise might. The same may be true for the bracelets, and some studies show them to be helpful with nausea after surgery. Nevertheless, the effects of a bracelet on postoperative ileus are unproven.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

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

入选标准

  • •any child who has undergone appendectomy for perforated appendicitis

排除标准

  • •age less than or equal to 5 years
  • •unable to chew gum safely
  • •interval appendectomy

研究组 & 干预措施

1 Wristband

Sham Comparator

Some patients will be randomized to wear a motion sickness wristband which does not have any drug effect.

干预措施: Motion sickness wristband (Device)

Chewing Gum

Experimental

Patients will be randomized to use chewing gum after surgery.

干预措施: Chewing Gum (Dietary Supplement)

Control

No Intervention

Usual post-operative care.

结局指标

主要结局

Time to resolution of post-operative ileus.

时间窗: 1-14 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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