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临床试验/NCT01956643
NCT01956643已完成不适用

Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2013年10月最近更新:
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
70
试验地点
2
主要终点
time to flatus

研究概览

简要总结

Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return of normal gut function Chewing gum has recently been used as a form of sham feeding to stimulate acceleration of gut function after abdominal surgery.

The investigators hypothesize that sham feeding with chewing gum will accelerate return of gut function after liver transplantation.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective liver transplantation surgery
  • an ability to chew gum

排除标准

  • emergency surgery
  • age less than 18 years,
  • inability to provide written informed consent
  • an inability to chew gum
  • hepaticojejunostomy
  • sedated patients
  • reintubated patients
  • Glasgow Coma Scale <13
  • reoperation before gas out
  • previous bowel surgery

研究组 & 干预措施

gum chewing

Experimental

Gum type was standardized with all subjects receiving sugar-free xylitol gum.

The patients in the chewing gum group, gum chewing began the morning of postoperative day 1. Patients chewed gum (two tablets) 3 times daily in the morning, afternoon, and evening for 15 min. The administration of the therapy was implemented by ICU nurses and recorded in the clinical report form file. All gum-chewing patients completed their course of gum chewing until gas out.

干预措施: gum chewing (Other)

Control

Placebo Comparator

Routine care during NPO

干预措施: Control (Other)

结局指标

主要结局

time to flatus

时间窗: an expected average of 75 hours

次要结局

  • percentage of target calories(an average 4 days)
  • ICU length of stay(an average 96 hous)
  • hospital length of stay(an average 20 days)

研究者

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

Ho Geol Ryu

Assistant Professor

Seoul National University Hospital

研究点 (2)

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