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

Sponsor
Hiroshima Kyoritsu Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02858596
Collaborator
(none)
136
2
23

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Semi-solid feed (Terumo PG soft)
  • Dietary Supplement: Liquid feed (Meibalance)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
136 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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 Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Semi-solid feed group

Given semi-solid feed protocol

Dietary Supplement: Semi-solid feed (Terumo PG soft)

Placebo Comparator: Liquid feed group

Given liquid feed protocol

Dietary Supplement: Liquid feed (Meibalance)

Outcome Measures

Primary Outcome Measures

  1. Incidence of aspiration pneumonia [through study completion, average 90 days postoperation]

Secondary Outcome Measures

  1. Postoperative length of stay [through study completion, average 90 days postoperation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hiroshima Kyoritsu Hospital

Investigators

  • Principal Investigator: Toh Yoon Wong, MD, Hiroshima Kyoritsu Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wong Toh Yoon, Chief Gastroenterologist, Hiroshima Kyoritsu Hospital
ClinicalTrials.gov Identifier:
NCT02858596
Other Study ID Numbers:
  • Semi-solid trial
First Posted:
Aug 8, 2016
Last Update Posted:
Aug 8, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2016