Different Feeding Methods After Pyloromyotomy

Not Applicable

Completed

• Conditions: Emesis
• Interventions: Other: ad lib feedings after pyloromyotomy; Other: FLAP diet after pyloromyotomy

• Registration Number: NCT01509417
• Lead Sponsor: Children's Mercy Hospital Kansas City

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 Description

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.

What all of these studies show us is that as a profession, Pediatric Surgery does not have the proper evidence to support any one post-op feeding regimen.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-12-14
• Primary Completion: 2012-01
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-13
• Study Completion: 2012-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ad lib feeding	FLAP diet after pyloromyotomy	ad lib feedings following pyloromyotomy
FLAP diet after pyloromyotomy	FLAP diet after pyloromyotomy	FLAP diet after pyloromyotomy
Ad lib feeding	ad lib feedings after pyloromyotomy	ad lib feedings following pyloromyotomy

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	up to 10 days

Secondary Outcome Measures

Name	Time	Method
number of emeses during stay	up to 10 days

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States