Interventions to Decrease the Impact of Post-Operative Ileus After Liver Transplant or Resection Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Timing of first post operative bowel movement
研究概览
简要总结
This is a randomized controlled trial to assess ways to address post-operative ileus (POI) in adult patients on the liver transplant service undergoing either liver transplant or resection surgery. Patient who speak and understand English will be randomized into one of three groups including a.)control group receiving standard therapy for post-operative ileus, b.)group receiving standard therapy and acupressure bracelets, and c.)group receiving standard therapy and sugar free gum four times daily.
详细描述
Any patient undergoing liver transplant or resection surgery will be asked to participate in the study and assigned to a control or investigational group. Pertinent information will be collected from the medical record including gender, age in years, diagnosis, type of surgery, length of stay, medications used for pain or nausea, and first bowel movement. The subjects will also be asked to keep a journal of their bowel habits, signs and symptoms of gastrointestinal distress/post-operative ileus, use of medications, first bowel movement, satisfaction with bowel management and any additional comments.
Aims of the study are to determine the effectiveness of the three arms of this trial for the resolution of POI as noted by first post-operative bowel movement; to determine if there is a difference in the length of stay based on the interventions; and to determine if there is a difference in patient satisfaction based on the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 19 years or older who speak and read English and have had a liver transplant or liver resection surgery
排除标准
- •Patients less than 19 years of age having liver transplant or liver resection surgery
- •Non-English speaking
- •Pregnancy
研究组 & 干预措施
Arm C
Sugar free gum
干预措施: sugar free gum (Dietary Supplement)
Arm A: Standard therapy (use of medications)
stool softener
干预措施: stool softener (Drug)
结局指标
主要结局
Timing of first post operative bowel movement
时间窗: Days post operative
First bowel movement
次要结局
- Length of hospital stay(Time from admission to discharge post surgery)