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?

This trial investigates the optimal timing for starting tube feeding after a procedure that places a feeding tube directly into the stomach (known as a PEG). It compares starting the feeding within one hour (the noFAST group) to starting it four hours after the procedure to determine which timing benefits patients more. The trial targets surgical or trauma patients on ventilators who can tolerate tube feeds before the procedure. Participants should not have any gastrointestinal issues that could complicate feeding. As an unphased trial, this study allows patients to contribute to important research that could enhance care for future 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.

What prior data suggests that early tube feeding after gastrostomy surgery is safe?

Research has shown that starting tube feeding soon after gastrostomy surgery is generally safe. One study found that patients who began feeding early after surgery reached their nutrition goals faster without experiencing more negative effects. Another study supported this, showing that feeding as soon as three hours after surgery is safe and effective.

The American Society for Gastrointestinal Endoscopy recommends starting feeding within four hours of surgery, rather than waiting. However, some experts believe more high-quality studies are needed to confirm the safety of this early feeding approach.

Overall, starting tube feeding soon after surgery does not seem to cause more problems than waiting longer. Patients should discuss any concerns with their healthcare team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new protocol for starting tube feeding shortly after gastrostomy surgery. Unlike the standard approach, which typically waits about four hours post-procedure to initiate feeding, this trial investigates the benefits of beginning feeds within just one hour. The earlier feeding could potentially improve patient recovery times, reduce hospital stays, and enhance overall patient comfort. By evaluating these potential benefits, researchers aim to determine if this expedited feeding protocol could become a new standard of care.

What evidence suggests that this trial's treatments could be effective for timing of enteral feeding after gastrostomy surgery?

This trial will compare two approaches to starting tube feedings after gastrostomy surgery. Research has shown that starting tube feedings soon, within one hour after placing a feeding tube directly into the stomach, can be safe and effective. Participants in the noFAST group will begin feeding within one hour after the procedure. Studies have found that patients who start feeding shortly after the procedure reach their nutritional goals faster without more complications. Participants in the FAST group will start feeding four hours after the procedure. A review of multiple studies found that starting feeds as early as four hours after the procedure does not increase the risk of health problems or death. The American Society for Gastrointestinal Endoscopy also supports starting feeding within four hours after the procedure. Overall, early feeding appears to be a promising approach for patients needing nutritional support after surgery. ^{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

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]

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 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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11117585/

Early initiation of post-PEG feeding: do published ... Recently published data have described the safety and efficacy of initiating PEG tube feedings as early as 3 hr after PEG tube placement.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480423005401

Early Versus Late Feeding After Percutaneous Endoscopic ... Patients with early initiation of feeds after PEG placement achieve a higher percentage of goals on day 0 without an increased rate of adverse events.

3. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/abs/10.1002/jpen.2774

Outcomes of early compared with delayed initiation of feeding ... This robust meta-analysis suggests early feeding after PEG placement is likely safe but uncertain, highlighting the need for a high-quality ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39368005/

Comparative Analysis of Early Versus Late Feeding Post ... This meta-analysis confirms that early feeding ≤ 4 h after PEG placement does not increase the odds of poor outcomes or mortality.

5. giejournal.org giejournal.org/article/S0016-5107(24)03505-3/fulltext

American Society for Gastrointestinal Endoscopy guideline ... The ASGE recommends that tube feeding can be safely started within 4 hours of gastrostomy. The ASGE suggests that PEG can be performed without ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40407236/

Outcomes of early compared with delayed initiation ... Conclusion: This robust meta-analysis suggests early feeding after PEG placement is likely safe but uncertain, highlighting the need for a high-quality ...