The Effect of Semi-solid Feeding After Percutaneous Endoscopic Gastrostomy (PEG) on the Incidence of Aspiration Pneumonia and Postoperative Length of Stay

Study Overview
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Brief Summary
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Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure for long-term enteral tube feeding in patients with insufficient oral intake. Although peristomal site infection is often noted as the most common adverse event after PEG tube placements, it is seldom life-threatening and considered a minor adverse event. Feeding-related adverse events have been identified as the main cause of death after PEG, with up to 50% of postoperative early mortality (30 days) being attributed to aspiration pneumonia. This may be related to the persistence of gastroesophageal reflux (GER) of enteral feed after gastrostomy, even though PEG have been demonstrated to be superior to nasogastric tube feeding in terms of preventing GER. It has been more than a decade since semi-solid feeds were developed as an alternative to conventional liquid feeds to prevent feeding-related adverse events. Unfortunately, there is limited published literature on this topic despite the wide usage of this feeding method in Japan. Amidst the growing popularity of this method and the introduction of National Healthcare Insurance coverage for semi-solid feed prescriptions, we initiated a semi-solid feed protocol along with our existing post-PEG feeding protocols in 2014.

Official Title
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The Effect of Semi-solid Feeding After Percutaneous Endoscopic Gastrostomy (PEG) on Clinical Outcomes, Specifically the Incidence of Aspiration Pneumonia and Postoperative Length of Stay

Conditions
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Gastrostomy, Aspiration Pneumonia

Intervention / Treatment
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* Dietary Supplement: Semi-solid feed (Terumo PG soft)
* Dietary Supplement: Liquid feed (Meibalance)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving gastrostomy tube placement in our hospital for enteral nutrition. Exclusion Criteria: Patients receiving gastrostomy tube placement for decompression Patients with no gut usage more than 2 weeks before procedure
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semi-solid feed group<br>Given semi-solid feed protocol | Dietary Supplement: Semi-solid feed (Terumo PG soft)<br> <br> |
| Placebo Comparator: Liquid feed group<br>Given liquid feed protocol | Dietary Supplement: Liquid feed (Meibalance)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of aspiration pneumonia |  | through study completion, average 90 days postoperation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of stay |  | through study completion, average 90 days postoperation |