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OpenTrials
Completed

NCT Number: NCT02858596

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-solid feed (Terumo PG soft)

Dietary Supplement

Liquid feed (Meibalance)

Dietary Supplement

Primary outcomes

  1. Incidence of aspiration pneumonia

    Time frame: through study completion, average 90 days postoperation

Secondary outcomes

  1. Postoperative length of stay

    Time frame: through study completion, average 90 days postoperation

Sponsors and collaborators

Lead sponsor

Hiroshima Kyoritsu Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 8, 2016
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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