View Clinical Trial (Medical Research Study)
Prospective Randomized Trial Evaluating the Feeding Regimen After Pyloromyotomy.
| City: |
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Kansas City |
| State: |
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Missouri |
| Zip Code: |
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64108 |
| Conditions: |
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Emesis |
| Purpose: |
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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.
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| Study Summary: |
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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 we
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 we wait 2
hours after surgery to start feeds. We 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 you start 4 hours post
surgery or wait 18 hours the time to full feeds is the same6. 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.
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| Criteria: |
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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)
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| NCT ID: |
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NCT01509417 |
| Primary Contact: |
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Principal Investigator
Shawn D St. Peter, MD
Children's Mercy Hospital and Clinics
Shawn D St. Peter, MD
Phone: 816 983-6479
Email: sspeter@cmh.edu
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| Backup Contact: |
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Email: swsharp@cmh.edu
Susan W Sharp, PhD
Phone: 816-983-6670
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| Location Contact: |
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Kansas City, Missouri 64108
United States
Shawn D St. Peter, MD
Phone: 816-983-6479
Email: sspeter@cmh.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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