- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01509417
Different Feeding Methods After Pyloromyotomy
Prospective Randomized Trial Evaluating the Feeding Regimen After Pyloromyotomy.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ad lib feeding
ad lib feedings following pyloromyotomy
|
ad lib feedings after pyloromyotomy
Other Names:
FLAP diet after pyloromyotomy
Other Names:
|
Active Comparator: FLAP diet after pyloromyotomy
|
FLAP diet after pyloromyotomy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of hospital stay
Time Frame: up to 10 days
|
up to 10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of emeses during stay
Time Frame: up to 10 days
|
up to 10 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10 05-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emesis
-
Mansoura UniversityUnknown
-
Karin JordanTerminated
-
Clinica Universidad de Navarra, Universidad de...Completed
-
Albany Medical CollegeCompleted
-
Hedvig Marie Egeland NordengCompletedMedication Adherence | Emesis | Pregnancy EarlyNorway
-
Hospital for Special Surgery, New YorkCompletedNausea | EmesisUnited States
-
S. Maria Hospital, TerniTerminated
-
University of PittsburghCompletedEmesisUnited States
-
Hedvig Marie Egeland NordengCompletedHyperemesis Gravidarum | Emesis | Emesis PregnancyNorway
-
Signe HarderCompleted
Clinical Trials on ad lib feedings after pyloromyotomy
-
Indiana UniversityCompletedPostoperative Feeding Following PyloromyotomyUnited States
-
Duke UniversityNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH); Food and Drug Administration (FDA)TerminatedCigarette Smoking | Nicotine WithdrawalUnited States
-
University of OklahomaNational Institute on Drug Abuse (NIDA); Oklahoma State UniversityRecruitingNicotine Dependence | Cigarette Smoking | Nicotine WithdrawalUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Baltimore VA Medical CenterCompletedPeripheral Arterial Occlusive DiseaseUnited States
-
Oregon Health and Science UniversityKaiser PermanenteCompletedObesity
-
PepsiCo Global R&DCompleted
-
Juul Labs, Inc.CompletedTobacco Use | Tobacco Smoking | Nicotine Dependence | Nicotine Dependence, CigarettesNew Zealand
-
Kansas City Heart Rhythm Research FoundationKansas City Heart and Rhythm Institute, Overland Park, KS; Bariatric and Metabolic...RecruitingOrthostatic Intolerance | Autonomic DysfunctionUnited States