Early Tube Feeding After Gastrostomy Surgery

(PEG Trial)

Overseen By Jordan Darden, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Aberrant GI anatomy, GI motility disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Randomized controlled trial to establish evidence on which to base timing of enteral feeding after bedside PEG placement in ventilated Trauma and Surgical ICU patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

How is the noFAST treatment different from other treatments for feeding after gastrostomy surgery?

The noFAST treatment is unique because it involves starting tube feeding within 1 hour after gastrostomy surgery, whereas traditional methods typically delay feeding for 12 to 24 hours. This approach aims to reduce fasting time, improve nutritional support, and potentially shorten hospital stays without increasing complications. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment noFAST group, which involves starting tube feeds within 1 hour of gastrostomy surgery?

Research shows that starting tube feeding soon after gastrostomy surgery is safe and does not increase complications. Studies in both adults and children have found that early feeding can reduce hospital stay without causing feeding-related issues. ^{2 3 4 5 6}

Who Is on the Research Team?

Katie L Bower, MD

Principal Investigator

Carilion Clinic, Virginia Tech Carilion School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are on mechanical ventilation in the ICU due to trauma or surgery and need a PEG tube for feeding. They must have been tolerating tube feeds before the procedure. It's not for those with gut motility issues, feed intolerance, abnormal GI anatomy, or if the PEG isn't placed at an ICU bedside.

Inclusion Criteria

I am over 18 years old.

I am not pregnant.

I am managing my tube feeds well before the procedure.

Exclusion Criteria

You have an unusual gastrointestinal structure.

I cannot have a PEG tube placed due to health reasons.

I have had trouble eating before getting a feeding tube.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Procedure Fasting

Participants undergo fasting prior to PEG tube placement

24 hours

In-hospital monitoring

Post-Procedure Feeding

Participants are randomized to start tube feeds either 4 hours or <1 hour after PEG tube placement

72 hours

Continuous in-hospital monitoring

Follow-up

Participants are monitored for complications and calorie deficit after the procedure

72 hours

In-hospital monitoring

What Are the Treatments Tested in This Trial?

Interventions

• noFAST group
• noFast: Start tube feeds within 1 hour of procedure

Trial Overview The study tests whether starting tube feeding within one hour after placing a PEG (feeding) tube is beneficial for ventilated patients in surgical and trauma ICUs. This randomized controlled trial aims to find the best timing for enteral nutrition under these conditions.

How Is the Trial Designed?

Group I: FAST: Start tube feeds 4 hours after procedure Active Control 1 Intervention

The FAST group will have post-PEG tube feeds initiated 4 hours after the procedure. Feeds are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.

Group II: noFast: Start tube feeds within 1 hour of procedure Active Control 1 Intervention

The noFAST group will have post-PEG tube feeds initiated \<1 hour after the procedure. Feeds are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Published Research Related to This Trial

In a study of 150 ventilated patients who underwent PEG tube placement, early feeding (starting within 4 hours) showed a low overall complication rate of 3.3%, indicating that it is a safe practice.

There was no significant difference in complication rates between early feeding (3.1%) and delayed feeding (3.4%), suggesting that early feeding after PEG placement does not increase risks for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early feeding after percutaneous endoscopic gastrostomy tube placement in patients who require trauma and surgical intensive care: A retrospective cohort study. Shahmanyan, D., Lawrence, JC., Lollar, DI., et al.[2022]

A study involving 41 patients found that initiating feeding through PEG tubes just 3 hours after placement is as safe as starting feedings 24 hours later, with no significant complications like peritonitis or systemic infection reported.

While three patients experienced significant residual volumes and one patient developed a local skin infection, these issues were manageable, suggesting that early feeding can be a viable option for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous endoscopic gastrostomy: a randomized prospective comparison of early and delayed feeding. Choudhry, U., Barde, CJ., Markert, R., et al.[2019]

In a study of 28 children aged 4 weeks to 20 years who underwent percutaneous endoscopic gastrostomy (PEG), starting enteral feedings just 6 hours after the procedure was found to be safe and effective.

All patients received their full feeding volume within 24 hours, and 12 out of 13 outpatients were discharged in less than 24 hours, indicating that early feeding can reduce hospitalization time without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early feeding after percutaneous endoscopic gastrostomy is safe in children. Werlin, S., Glicklich, M., Cohen, R.[2017]

A meta-analysis of five randomized clinical trials involving 355 adult subjects found that early tube feeding (within 3 hours) after percutaneous endoscopic gastrostomy (PEG) placement does not significantly increase complications compared to delayed feeding.

There were no significant differences in mortality within 72 hours or in the amount of gastric residual volume on the first day between early and delayed feeding groups, suggesting that early feeding is a safe option after PEG placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral feeding within three hours after percutaneous endoscopic gastrostomy placement: a meta-analysis. Szary, NM., Arif, M., Matteson, ML., et al.[2011]

A meta-analysis of six studies involving 467 adult patients found that early feeding (within 4 hours) after PEG placement is a safe alternative to delayed feeding, with no significant increase in overall complications or mortality within 72 hours.

However, early feeding was associated with a statistically significant increase in gastric residual volumes on the first day, indicating that while it is safe, monitoring may be necessary to manage this side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus delayed feeding after placement of a percutaneous endoscopic gastrostomy: a meta-analysis. Bechtold, ML., Matteson, ML., Choudhary, A., et al.[2009]

A study involving 112 patients showed that starting feeding through a PEG tube just 4 hours after placement is safe and well tolerated, with only minor complications reported.

Early feeding (4 hours) resulted in a higher rate of gastric retention on the first day compared to feeding after 24 hours, but overall, early feeding can reduce hospital stays and costs without significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized prospective trial of early versus delayed feeding after percutaneous endoscopic gastrostomy placement. McCarter, TL., Condon, SC., Aguilar, RC., et al.[2004]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Early feeding after percutaneous endoscopic gastrostomy tube placement in patients who require trauma and surgical intensive care: A retrospective cohort study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Percutaneous endoscopic gastrostomy: a randomized prospective comparison of early and delayed feeding. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Early feeding after percutaneous endoscopic gastrostomy is safe in children. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Enteral feeding within three hours after percutaneous endoscopic gastrostomy placement: a meta-analysis. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Early versus delayed feeding after placement of a percutaneous endoscopic gastrostomy: a meta-analysis. [2009]

6. United States pubmed.ncbi.nlm.nih.gov

Randomized prospective trial of early versus delayed feeding after percutaneous endoscopic gastrostomy placement. [2004]