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临床试验/NCT01509417
NCT01509417已完成不适用

Prospective Randomized Trial Evaluating the Feeding Regimen After Pyloromyotomy.

Children's Mercy Hospital Kansas City2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年7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
150
试验地点
2
主要终点
Length of hospital stay

研究概览

简要总结

The objective of this study is to scientifically evaluate the ability to discharge patients based on feeding schedule comparing ad lib feeds to our current scheduled regimen.

The hypothesis is that patients may be able to be discharged sooner with ad lib feeds.

详细描述

Hypertrophic pyloric stenosis is a common disease occurring in 2 per 1,000 live births1. Pyloric stenosis is a hypertrophy of the pyloric muscle which prevents emptying of the stomach leading to gastric outlet obstruction. The vomiting that ensues becomes projectile and results in severe dehydration. Traditionally this has been repaired with the pyloromyotomy via a transverse incision in the right upper quadrant. In the last decade the investigators have started doing the same procedure laparoscopically. Most institutions follow similar guidelines as to what constitutes a hypertrophic pyloric channel, initial electrolyte management and resuscitation prior to surgery, as well as the pyloromyotomy (either open or laparoscopically).

Historically patients were fed the day after surgery, then 6 hours, and currently the investigators wait 2 hours after surgery to start feeds. The investigators go through a protocol of 2 rounds of clear liquids, 2 rounds of half strength formula/breast milk then 2 rounds of full strength. Some centers have advocated ad lib feeds where babies go straight to full strength as tolerated when awake from the operation.

Institutional variability is even further confounded by individual attending variability in some instances. Recent articles in the past two decades still prove that no consensus has been found. Some institutions profess that Ad Libitum feeding is both cost-effective as well as safe, but very few institutions to our knowledge follow this mantra. Others demand that no feeds should be started within 4 hours post surgery stating that the increased vomiting associated with this early feeding regimen actually prolongs the time to full feeds due to anxiety and discomfort. What has been shown is that no matter whether patients start 4 hours post surgery or wait 18 hours the time to full feeds is the same. All of these studies are hindered by the fact that they all have retrospective components to their design.

What has also been propagated in two recent retrospective reviews is the implementation of clinical pathways as well as standardized feeding regimens. Both of these showed a decrease in length of stay postoperatively as well as hospital costs.

At our institution a clinical pathway and feeding regimen has been implemented. The feeding regimen contrary to some of the previously quoted papers starts at 2 hours with sequential feeding increases. A prospectively acquired dataset at our institution has shown that emesis is correlated to the degree of dehydration of the child prior to surgery even with all the children being on the same clinical pathway.

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
1 Day 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patients who are diagnosed with pyloric stenosis and scheduled for laparoscopic pyloromyotomy. -

排除标准

  • Open procedures
  • Patient has alternative diagnosis that would affect feeding (like mucosal perforation)

结局指标

主要结局

Length of hospital stay

时间窗: up to 10 days

次要结局

  • number of emeses during stay(up to 10 days)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Sponsor

研究点 (2)

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