search
Back to results

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
Hiroshima Kyoritsu Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastrostomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 1, 2016
    Last Updated
    August 5, 2016
    Sponsor
    Hiroshima Kyoritsu Hospital
    search

    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
    background
    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
    background
    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
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs