Pre-ERCP Carbohydrate Drinks Improve Patients Recovery: an ERAS Protocol Attempts in ERCP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,292
- 试验地点
- 15
- 主要终点
- Abdominal pain
研究概览
简要总结
To test the benefits of extra high carbohydrate liquid diet uptake 2 hours before ERCP in improving patients' early recovery.
详细描述
Enhanced recovery after surgery (ERAS) has been formed of procedure which contains preoperative education, improvement of anesthesia, reducing the number of drainage tubes, and early diet after surgery. In recent years, because of its positive advantages, ERAS was widely accepted in surgical fields.
For upper gastrointestinal surgery, high-carbohydrate drinks can be given 2 hours before surgery in order to guarantee the stability of blood glucose and circulation during the operation. It obviously reduce the preoperative thirst, hunger, irritability and even the incidence of postoperative complications.
However ERAS program is rarely studied in ERCP. Theoretically we can use ERAS as a strategy to reduce post-ERCP uncomfortable and complications.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ERCP patients,
- •Age 18-85 years old.
排除标准
- •Coagulation dysfunction (INR> 1.3) and low peripheral blood platelet count(<50×109 / L) or using anti-coagulation drugs,
- •Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, shock, liver or kidney malfunction,
- •Diabetes（blood glucose fluctuations）or with complications,
- •Intestinal obstruction or other contraindications with feeding and watering,
- •Prior surgery of Bismuth Ⅱ and Roux-en-Y,
- •Pregnant women,
- •Unwillingness or inability to consent for the study.
研究组 & 干预措施
High carbohydrate liquid diet
No need preoperative fasting more than 6 hours. Uptake 400ml high carbohydrate liquid diet 2 hours before ERCP.
干预措施: 400ml high carbohydrate liquid diet before ERCP (Procedure)
Routine ERCP group
Preoperative fasting more than 6 hours as usual.
结局指标
主要结局
Abdominal pain
时间窗: 6 months
Pain score (scores:1-10)
Levels of fatigue (Fatigue Scale-14 scoring system)
时间窗: 6 months
The patients always feel tired and faint. The clinical manifestation includes slow to respond, the flexibility and coordination disorders.
次要结局
- The time eating(6 months)
- The average incubation time(6 months)
- Length of hospital stay(6 months)
- Successful cannulation time(6 months)
- Postoperative abdominal distention(6 months)
- Intraoperative residues in stomach(6 months)
- Postoperative nausea and vomiting(6 months)
- Complications(6 months)
- Blood glucose(6 months)
研究者
Xun Li
M.D., Ph. D, Direct of surgery
Hepatopancreatobiliary Surgery Institute of Gansu Province