Clinical Trial: Different Feeding Methods After Pyloromyotomy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective Randomized Trial Evaluating the Feeding Regimen After Pyloromyotomy.
Brief Summary:
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.
Detailed Summary:
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
Sponsor: Children's Mercy Hospital Kansas City
Current Primary Outcome: Length of hospital stay [ Time Frame: up to 10 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: number of emeses during stay [ Time Frame: up to 10 days ]
Original Secondary Outcome: Same as current
Information By: Children's Mercy Hospital Kansas City
Dates:
Date Received: December 14, 2011
Date Started: July 2010
Date Completion:
Last Updated: May 28, 2013
Last Verified: May 2013
