Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Post-operative severe pancreatic fistula (Grade B and C)
研究概览
简要总结
Major digestive surgery is associated with a significant rate of postoperative complications. To improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation. However, the rehabilitation concept does not allow to improve muscular and functional reserves at the time of surgery. Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. Also, the prevalence of sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients with pancreatic cancer, with a considerable impact on postoperative and survival outcomes.
The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Patients undergoing pancreaticoduodenectomy for cancer
- •Sarcopenic status
排除标准
- •Age younger than 18 years
- •Medical contraindications including cardiovascular disease or clinically significant vascular disease
- •Physical inability to exercise
- •Emergent surgery
研究组 & 干预措施
PREHAB
干预措施: Prehabilitation program (Other)
control group
干预措施: Oral Impact (Dietary Supplement)
结局指标
主要结局
Post-operative severe pancreatic fistula (Grade B and C)
时间窗: at 90 days
Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)
次要结局
- Rate of program completion(at 30 days)
- Rate of Severe postoperative complications(at 90 days)
- Overall survival(at 1 year and at 3 years)
- Program acceptance measure by Modified ACCEPT© questionnaire(at 30 days)
- Satisfaction questionnaire by EVAN-G(at 30 days)
- Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45)(at 30 days)
- Quality of life by EORTC-QLQc30 scale(at 1 month, 3 months, 6 months and at 1 year)