EmesisNCT01509417
Different Feeding Methods After Pyloromyotomy
A study testing ad lib feedings after pyloromyotomy and FLAP diet after pyloromyotomy in people with Emesis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Emesis
- What is being tested?
- ad lib feedings after pyloromyotomy and FLAP diet after pyloromyotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who are diagnosed with pyloric stenosis and scheduled for laparoscopic pyloromyotomy. -
Who cannot join
- Open procedures
- Patient has alternative diagnosis that would affect feeding (like mucosal perforation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: 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.
Read the 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.
- Conditions
- Emesis
- Being tested
- ad lib feedings after pyloromyotomy, FLAP diet after pyloromyotomy
- Keywords
- pyloric stenosis
- Medical subject headings
- Vomiting, Pyloric Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ad lib feedings after pyloromyotomyOther
Also called post surgical refeeding ad lib
ad lib feedings after pyloromyotomy
FLAP diet after pyloromyotomyOther
Also called Post surgical FLAP refeeding
FLAP diet after pyloromyotomy
| Study group | Role | What they receive |
|---|---|---|
| Ad lib feeding | Experimental | ad lib feedings following pyloromyotomy Receives: Other: ad lib feedings after pyloromyotomy; Other: FLAP diet after pyloromyotomy |
| FLAP diet after pyloromyotomy | Active comparator | FLAP diet after pyloromyotomy Receives: Other: FLAP diet after pyloromyotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: up to 10 days
Secondary outcomes (1)
number of emeses during stay
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startJul 2010
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shawn D St. Peter, MD, Principal investigator, Children's Mercy Hospital and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509417
- Sponsor's protocol ID
- 10 05-101
- Status last verified
- May 2013
- First submitted
- 14 Dec 2011
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Evaluating the Feeding Regimen After Pyloromyotomy.
- ClinicalTrials.gov ID
- NCT01509417
- Acronym / sponsor ID
- 10 05-101
- Conditions
- Emesis
- Keywords
- pyloric stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ad lib feeding | Experimental | Other: ad lib feedings after pyloromyotomy, Other: FLAP diet after pyloromyotomyad lib feedings following pyloromyotomy |
| FLAP diet after pyloromyotomy | Active comparator | Other: FLAP diet after pyloromyotomyFLAP diet after pyloromyotomy |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients who are diagnosed with pyloric stenosis and scheduled for laparoscopic pyloromyotomy. -
Key exclusion criteria (2 listed)
- Open procedures
- Patient has alternative diagnosis that would affect feeding (like mucosal perforation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ad lib feedings after pyloromyotomyAlso: post surgical refeeding ad libad lib feedings after pyloromyotomy | Other | Ad lib feeding |
| FLAP diet after pyloromyotomyAlso: Post surgical FLAP refeedingFLAP diet after pyloromyotomy | Other | Ad lib feeding, FLAP diet after pyloromyotomy |
Primary outcome
Length of hospital stay
Time frame: up to 10 days
1 secondary outcome
number of emeses during stay
Time frame: up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
Related trials for Emesis
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
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Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
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Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
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Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum
Hyperemesis Gravidarum, Nausea and Vomiting of Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn D St. Peter, MD principal investigator
Children's Mercy Hospital and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ad lib feedings after pyloromyotomy and FLAP diet after pyloromyotomy in people with Emesis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.