Application of Enhanced Recovery After Surgery During the Perioperative Period in Infants With Choledochal Cyst- a Multi-center Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- postoperative length of stay
研究概览
简要总结
Recently, with reference to the successful experience of accelerated rehabilitation surgery in the field of adult surgery, the investigators have conducted studies on ERAS in pediatric and even infant cholangiectasia surgery to discuss its feasibility and safety. The results showed that some items of ERAS could be safely applied in perioperative management of CBD, and could reduce traumatic stress and promote postoperative recovery. Therefore, the investigators assumed that the ERAS protocols could be safely applied in the treatment of CBD in children and even infants, reducing traumatic stress in children with CBD, promoting postoperative rehabilitation, reducing complications and hospitalization time, reducing hospitalization costs, and saving medical resources.
详细描述
- Optimize preoperative, intraoperative and postoperative perioperative management by learning from the successful experience of accelerated rehabilitation surgery model in other fields.
For example: necessary and sufficient preoperative education of children and guardians; short fasting before surgery; oral carbohydrate at 2h before surgery; breast feeding at 4h before surgery (formula feeding at 6h before surgery); improved intestinal preparation; irregular placement of nasogastric tube; the use of general anesthesia plus epidural or sacral block anesthesia during surgery; attention to the whole process of heat preservation; strict control of infusion volume; and selection of minimally invasive hands Methods of operation; early postoperative activity, multi-mode analgesia, etc. 2. According to the pathophysiological characteristics of infants with cholangiectasia, several aspects were studied: minimally invasive surgery；promote gastrointestinal motor function recovery；develop principles and plans for early postoperative feeding；Rational placement of abdominal drainage tube; precise choice of anesthesia method, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 0-12 months
- •According to the clinical manifestations and preoperative imaging examination, the children admitted to hospital were diagnosed with choledochal cyst
- •The legal guardian of the child signs the Informed Consent
排除标准
- •Have potentially life-threatening diseases of various organ systems
- •Preoperatively associated with other diseases that interfere with the treatment process of the child
- •Caroli's disease was diagnosed
- •Any other condition that the investigator deems unsuitable for participation in the trial
结局指标
主要结局
postoperative length of stay
时间窗: through study completion, an average of 1 year
To record the postoperative length of stay
次要结局
- IL-6 level(24 hours after surgery)
- gastrointestinal functional recovery(through study completion, an average of 1 month)
- Blood cortisol level(24 hours after surgery)
- C-reactive protein (CRP)(24 hours after surgery)
- complication rate(one month after surgery)
- Gastrointestinal decompression tube indwelling time(through study completion, an average of 1 month)
- Peritoneal drainage tube indwelling time(through study completion, an average of 1 month)
- IL-10 level(24 hours after surgery)
- Parents satisfaction score(through study completion, an average of 1 month)
- 30-day readmission rate(one month after surgery)
- Hospitalization expenses(through study completion, an average of 1 month)
研究者
Weibing Tang
professor
Nanjing Children's Hospital