Different Feeding Methods After Pyloromyotomy
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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. |
- Length of hospital stay [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
- number of emeses during stay [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ad lib feeding |
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 |
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 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.
Eligibility| Ages Eligible for Study: | up to 3 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Shawn D St. Peter, MD | 816 983-6479 | sspeter@cmh.edu |
| Contact: Susan W Sharp, PhD | 816-983-6670 | swsharp@cmh.edu |
| United States, Missouri | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Shawn D St. Peter, MD 816-983-6479 sspeter@cmh.edu | |
| Contact: Susan W Sharp, PhD 816-983-6670 swsharp@cmh.edu | |
| 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: | January 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Mercy Hospital Kansas City:
|
pyloric stenosis |
ClinicalTrials.gov processed this record on May 19, 2013