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

Not Applicable

Completed

• Conditions: Aspiration Pneumonia; Gastrostomy
• Interventions: Dietary Supplement: Semi-solid feed (Terumo PG soft); Dietary Supplement: Liquid feed (Meibalance)

• Registration Number: NCT02858596
• Lead Sponsor: Hiroshima Kyoritsu Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-08
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-05
• Last Update Submitted: 2016-08-05
• Study First Posted: 2016-08-08
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semi-solid feed group	Semi-solid feed (Terumo PG soft)	Given semi-solid feed protocol
Liquid feed group	Liquid feed (Meibalance)	Given liquid feed protocol

Primary Outcome Measures

Name	Time	Method
Incidence of aspiration pneumonia	through study completion, average 90 days postoperation

Secondary Outcome Measures

Name	Time	Method
Postoperative length of stay	through study completion, average 90 days postoperation