The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme, a Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Recovery of gastro-intestinal function
研究概览
简要总结
The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol.
Hypothesis The use of Movicol® during one week prior to partial liver resection combined with the Enhanced Recovery After Surgery (ERAS®) programme accelerates functional recovery by promoting early return of gastro-intestinal function, defined as the passage of stools and early oral intake.
详细描述
Rationale:
The routine use of laxatives after liver surgery as part of an Enhanced Recovery After Surgery (ERAS®) programme enhances recovery of gastro-intestinal function and early tolerance of oral nutrition. The use of Macrogol (Movicol®) as laxative during one week prior to partial liver resection will further enhance early return of gastro-intestinal function and accelerate functional recovery.
Objective:
The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol®
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a partial liver resection
- •Able to understand the nature of the study and what will be required of them
- •Men and non-pregnant, non-lactating women between age 18-80
- •BMI between 18-35
- •Patients with ASA I-III
排除标准
- •Inability to give written informed consent
- •Patients requiring bile duct reconstruction
- •Patients with ASA IV-V
- •Superextended hepatectomy
- •Underlying symptomatic liver disease such as cirrhosis
- •Underlying gastro-intestinal disease such as motility disorders
- •Need for procedures additive to partial liver resection
研究组 & 干预措施
Movicol
Administration of 1 sachet of Movicol® daily during one week preoperatively (experimental care) and 2 sachets of Movicol® daily postoperatively (standard care).
干预措施: Movicol (Drug)
结局指标
主要结局
Recovery of gastro-intestinal function
时间窗: 20 days
Recovery of gastro-intestinal function defined as time to first intake of solid food continued for more than 24 hours
次要结局
- Functional recovery(20 days)
- Hospital length of stay(20 days)
- Recovery of gastro-intestinal function(20 days)