Different Feeding Methods After Pyloromyotomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01509417
First received: December 14, 2011
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Emesis
Other: ad lib feedings after pyloromyotomy
Other: FLAP diet after pyloromyotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Evaluating the Feeding Regimen After Pyloromyotomy.

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of emeses during stay [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: July 2010
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ad lib feeding
ad lib feedings following pyloromyotomy
Other: ad lib feedings after pyloromyotomy
ad lib feedings after pyloromyotomy
Other Name: post surgical refeeding ad lib
Other: FLAP diet after pyloromyotomy
FLAP diet after pyloromyotomy
Other Name: Post surgical FLAP refeeding
Active Comparator: FLAP diet after pyloromyotomy
FLAP diet after pyloromyotomy
Other: FLAP diet after pyloromyotomy
FLAP diet after pyloromyotomy
Other Name: Post surgical FLAP refeeding

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.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509417

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital and Clinics
  More Information

No publications provided

Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01509417     History of Changes
Other Study ID Numbers: 10 05-101
Study First Received: December 14, 2011
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
pyloric stenosis

ClinicalTrials.gov processed this record on July 23, 2014