NCT07017361尚未招募不适用
A Multicenter Randomized Prospective Study on Establishing an ERAS Program and Optimized Clinical Protocol for Patients Undergoing Minimally Invasive Pancreatoduodenectomy (MIPD)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Proportion of Participants Meeting Discharge Criteria by Post-operative Day 5 Afternoon
研究概览
简要总结
To evaluate the impact of an Enhanced Recovery After Surgery (ERAS) program on postoperative recovery in patients undergoing minimally invasive pancreatoduodenectomy (MIPD)
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years, scheduled for standard minimally invasive (robotic or laparoscopic) pancreatoduodenectomy for periampullary tumors
- •ECOG performance status of 0 or 1 at screening
- •Able to provide written informed consent, understand study procedures, and complete patient-reported questionnaires
- •ASA physical status classification I-III
排除标准
- •Hypersensitivity to fentanyl or ropivacaine
- •Cognitive impairment preventing independent use of patient-controlled analgesia or completion of questionnaires
- •Major internal medical or psychiatric disorders affecting treatment response
- •Severe hepatic or renal dysfunction
- •Any condition deemed inappropriate for study participation by the investigator
研究组 & 干预措施
ERAS
Experimental
干预措施: ERAS (Procedure)
Conventional
Active Comparator
干预措施: Conventional (Procedure)
结局指标
主要结局
Proportion of Participants Meeting Discharge Criteria by Post-operative Day 5 Afternoon
时间窗: Up to the afternoon of Post-operative Day 5
次要结局
- Length of Post-operative Hospital Stay (Days)(Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30))
- Incidence of Major Complications (Clavien-Dindo ≥ Grade IIIa) Within 30 Days(Post-operative Day 0 to Day 30)
- Total Direct Medical Costs per Participant (KRW) During Index Hospitalization(Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30))
研究者
Wooil Kwon
Associate Professor
Seoul National University Hospital
研究点 (1)
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