跳至主要内容
临床试验/NCT02858596
NCT02858596已完成不适用

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

Hiroshima Kyoritsu Hospital0 个研究点目标入组 136 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
136
主要终点
Incidence of aspiration pneumonia

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients receiving gastrostomy tube placement in our hospital for enteral nutrition.

排除标准

  • •Patients receiving gastrostomy tube placement for decompression
  • •Patients with no gut usage more than 2 weeks before procedure

研究组 & 干预措施

Liquid feed group

Placebo Comparator

Given liquid feed protocol

干预措施: Liquid feed (Meibalance) (Dietary Supplement)

Semi-solid feed group

Experimental

Given semi-solid feed protocol

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

结局指标

主要结局

Incidence of aspiration pneumonia

时间窗: through study completion, average 90 days postoperation

次要结局

  • Postoperative length of stay(through study completion, average 90 days postoperation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wong Toh Yoon

Chief Gastroenterologist

Hiroshima Kyoritsu Hospital

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