Clinical trial NCT02858596: The Effect of Semi-solid Feeding After Percutaneous Endoscopic Gastrostomy (PEG) on the Incidence of Aspiration Pneumonia and Postoperative Length of Stay
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrostomy
Aspiration Pneumonia
Lead sponsor: Hiroshima Kyoritsu Hospital
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of aspiration pneumonia
timeFrame: through study completion, average 90 days postoperation
Secondary outcomes:
measure: Postoperative length of stay
timeFrame: through study completion, average 90 days postoperation
Other outcomes:
Locations:
Study officials:
affiliation: Hiroshima Kyoritsu Hospital
name: Toh Yoon Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Tanishima Y, Fujita T, Suzuki Y, Kawasaki N, Nakayoshi T, Tsuiboi K, Omura N, Kashiwagi H, Yanaga K. Effects of half-solid nutrients on gastroesophageal reflux in beagle dogs with or without cardioplasty and intrathoracic cardiopexy. J Surg Res. 2010 Jun 15;161(2):272-7. doi: 10.1016/j.jss.2009.03.025. Epub 2009 Apr 19.