The Effect of Semi-solid Feeding After Percutaneous Endoscopic Gastrostomy (PEG) on the Incidence of Aspiration Pneumonia and Postoperative Length of Stay
Primary Purpose
Gastrostomy, Aspiration Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Semi-solid feed (Terumo PG soft)
Liquid feed (Meibalance)
Sponsored by
About this trial
This is an interventional prevention trial for Gastrostomy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Semi-solid feed group
Liquid feed group
Arm Description
Given semi-solid feed protocol
Given liquid feed protocol
Outcomes
Primary Outcome Measures
Incidence of aspiration pneumonia
Secondary Outcome Measures
Postoperative length of stay
Full Information
NCT ID
NCT02858596
First Posted
August 1, 2016
Last Updated
August 5, 2016
Sponsor
Hiroshima Kyoritsu Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02858596
Brief Title
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hiroshima Kyoritsu Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrostomy, Aspiration Pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Semi-solid feed group
Arm Type
Experimental
Arm Description
Given semi-solid feed protocol
Arm Title
Liquid feed group
Arm Type
Placebo Comparator
Arm Description
Given liquid feed protocol
Intervention Type
Dietary Supplement
Intervention Name(s)
Semi-solid feed (Terumo PG soft)
Intervention Type
Dietary Supplement
Intervention Name(s)
Liquid feed (Meibalance)
Primary Outcome Measure Information:
Title
Incidence of aspiration pneumonia
Time Frame
through study completion, average 90 days postoperation
Secondary Outcome Measure Information:
Title
Postoperative length of stay
Time Frame
through study completion, average 90 days postoperation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toh Yoon Wong, MD
Organizational Affiliation
Hiroshima Kyoritsu Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21562643
Citation
Shizuku T, Adachi K, Furuta K, Niigaki M, Miyaoka Y, Katoh S, Kobayashi K, Otani M, Kawashima K, Otani J, Kinoshita Y. Efficacy of half-solid nutrient for the elderly patients with percutaneous endoscopic gastrostomy. J Clin Biochem Nutr. 2011 May;48(3):226-9. doi: 10.3164/jcbn.10-108. Epub 2011 Apr 13.
Results Reference
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PubMed Identifier
19501431
Citation
Adachi K, Furuta K, Morita T, Nakata S, Ohara S, Tanimura T, Koshino K, Miki M, Ishimura N, Inoue Y, Ryuko K, Umegae N, Ohhata S, Katoh S, Yamamoto K, Nariai Y, Hashimoto Y, Sumi A, Kawaguchi M, Kinoshita Y. Half-solidification of nutrient does not decrease gastro-esophageal reflux events in patients fed via percutaneous endoscopic gastrostomy. Clin Nutr. 2009 Dec;28(6):648-51. doi: 10.1016/j.clnu.2009.05.006. Epub 2009 Jun 5.
Results Reference
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PubMed Identifier
19487579
Citation
Nishiwaki S, Araki H, Shirakami Y, Kawaguchi J, Kawade N, Iwashita M, Tagami A, Hatakeyama H, Hayashi T, Maeda T, Saitoh K. Inhibition of gastroesophageal reflux by semi-solid nutrients in patients with percutaneous endoscopic gastrostomy. JPEN J Parenter Enteral Nutr. 2009 Sep-Oct;33(5):513-9. doi: 10.1177/0148607108327045. Epub 2009 Jun 1.
Results Reference
background
PubMed Identifier
19577758
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.
Results Reference
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The Effect of Semi-solid Feeding After Percutaneous Endoscopic Gastrostomy (PEG) on the Incidence of Aspiration Pneumonia and Postoperative Length of Stay
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