A Prospective Randomized Controlled Trial Evaluating an Accelerated 5 Day Pathway for Discharge Following Pancreaticoduodenectomy (PD): Whipple Accelerated Recovery Pathway (WARP Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Percentage of Patients Discharged by Post-operative Day 5
研究概览
简要总结
This randomized clinical trial studies accelerated recovery pathway for discharge after surgery in patients with pancreatic cancer. A standardized accelerated recovery pathway may improve outcomes after surgery following complex abdominal operations resulting in a shorter length of stay in patients with pancreatic cancer. It may also help patients to mobilize more quickly and return to the home setting, decrease hospital-acquired infectious complications, and increase potential cost savings. It is not yet known whether an accelerated recovery pathway is better than a standard recovery pathway for discharge following surgery in patients with pancreatic cancer.
详细描述
PRIMARY OBJECTIVES:
I. The use of an accelerated pathway will result in a shorter postoperative hospital length of stay for patients undergoing pancreaticoduodenectomy (PD) without an increase in perioperative complications or readmission rates.
SECONDARY OBJECTIVES:
I. The investigators anticipate lower cost, lower readmission rate, similar rate of post-operative complications (delayed gastric emptying [DGE], anastomotic leaks, intra-abdominal abscesses, wound infection, urinary tract infection [UTI], respiratory compromise, renal failure, etc.) in our study group.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pancreaticoduodenectomy
- •Firm gland texture
- •Subjects able to provide informed consent
排除标准
- •Preoperative factors:
- •Congestive heart failure (CHF)
- •End stage renal disease (ESRD)
- •Chronic obstructive pulmonary disease (COPD)
- •Pregnancy
- •Albumin < 3 gm/dL
- •Poor preoperative performance status as defined by: timed get up and go (< 15 seconds)
- •Patients cannot be homeless or have substance dependence
- •Intraoperative factors:
- •Estimated blood loss (EBL) > 1 liter
- •Failure to extubate at the conclusion of the case
- •Operative time > 8 hours
- •Need for vascular resection/reconstruction
结局指标
主要结局
Percentage of Patients Discharged by Post-operative Day 5
时间窗: Up to post-operative day 5
Two-sided alpha 0.05 will be used to detect a increase in the percentage of patients discharged on post-operative day 5
次要结局
- Post-operative Median Length of Stay(30 days after operation)
- Readmission Rate(30 days after operation)
- Cost(30 days after operation)
- Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.)(30 days after operation)