The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- Morbidity
研究概览
简要总结
Enhanced Recovery After Surgery (ERAS) is not the program that aim to reduce postoperative hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve the restoration of,functional capacity after surgery on evidence-based medicine. The benefits of ERAS is proved in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation) is still one of most complex abdominal surgery, and there is no evidence that ERAS is beneficial on PD.
This study investigate the clinical effectiveness of ERAS on PD.
详细描述
- This study conduct totally 276 patients who underwent PD with borderline or malignant periampullary tumor. The patients divided into two groups. One group take conventional, experienced-based perioperative management, the other group take perioperative management based on ERAS protocol. Applied ERAS protocol is based on "Guidelines for Perioperative Care for Pancreaticoduodenectomy: Ehanced Recovery After Surgery Society Recommendations.
- The outcomes are analyzed for short-term surgical outcomes including operative factors, nutritional status, morbidity, mortality, length of stay, readmission, etc.
- Among all subjects who were randomized and started any study intervention (ERAS or standard perioperative management), the patients who underwent pancreaticoduodenectomy were included as the Full analysis set (FAS). All subjects who didn't undergo pancreaticoduodenectomy were excluded from this study.
- Besides, as all subjects who were randomized and received any study intervention were obliged to follow the study protocol and monitored for best compliance, per-protocol set or safety set were not defined differently
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
- Single (Outcomes Assessor)
盲法说明
The evaluation and judgement for morbidity (primary endpoint) / mortality (secondary endpoint) was made by Morbidity and Mortality Committee in our division. Committee members were blinded about knowledge of the interventions assigned to individual participants.
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
- •>18 years old or <75 years old
- •resectable periampullary cancer or borderline malignancy
- •no distant metastasis
- •no functional disturbance in bone marrow; WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
- •no functional disturtance in liver; Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal
- •no function disturbance in kidney; Creatinine no greater than 1.5 times upper limit of normal
- •informed consent
排除标准
- •distant metastasis (+) or recurred periampullary tumor
- •active or uncontrolled infection
- •uncontrolled psychiatric or neurologic problems
- •alcohol or other drug addiction
- •already enrolled patient in other study which affect this study
- •the patient who is impossible to allow investigator's order
- •pregnant or the possibility of pregnancy (+)
- •uncontrolled cardiopulmonary disease
- •moderate to severe comorbidity which affect on the quality of life and nutritional status (liver cirrhosis, end stage renal disease, heart failure, etc.)
- •previous history of major gastrointestinal surgery (gastrectomy, colectomy, etc.)
- •in preoperative period, expected combined resection of other gastrointestinal organ including portal vein
结局指标
主要结局
Morbidity
时间窗: 3 months
The incidence of operation-related morbidity
次要结局
- Mortality(3 months)
- length of stay(3 months)
- nutritional status(3 months)
研究者
Dae Wook Hwang
Assistant professor
Asan Medical Center