Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP(Hepatobiliary and Pancreatic) Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- The incidence and severity of general complication
研究概览
简要总结
Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy.
详细描述
The most important outcome in the management of HBP malignancies is survival. Since the application of ERAS (enhanced recovery after surgery), the improvement of QOL(quality of life) has been known as one of important factor for the management of HBP malignancies as well as survival, and the improvement of QOL, itself, affect the survival.
There are several reports that perioperative rehabilitation affect positively for the outcome of surgery and QOL in surgical patients. However, in the HBP field, there are rarely studied for this concept.
This study aim to investigate that the application of rehabilitation program for the surgery of HBP malignancies affect on short-term outcome and lead the improvement of QOL.
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
- Single (Outcomes Assessor)
盲法说明
The result of allocation in control and intervention group would be blinded to primary and secondary outcomes assessor.
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 <80 years old
- •resectable HBP malignancies or premalignant lesions which should be required GI resection and anastomosis
- •open surgery
- •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 disturbance in liver; 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 HBP tumor
- •active or uncontrolled infection
- •alcohol or other drug addiction
- •already enrolled patient in other study which affect this study
- •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.)
- •previous history of neurological or musculoskeletal diseases which is impossible to allow investigator's order
结局指标
主要结局
The incidence and severity of general complication
时间窗: till postoperative 3 months
Incidence rate and severity of general complications except operation-specific complication, according to Clavien-Dindo classification
次要结局
- The incidence of operation-specific complication(till postoperative 3 months)
- Compliance of Aerobic exercise, strength exercise and respiratory excursion (Changes in the parameters of rehabilitation)(Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery)
- The changes in Quality of life(Comparison between at the time of discharge and postoperative 3months)
- The incidende of Mortality(till postoperative 3 months)
- Rate of re-admission(till postoperative 3 months)
- Measurement on 6 minutes walk test (m/minute) (Changes in the parameters of rehabilitation)(Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery)
- Grasping power(dynamometer, kg)(Changes in the parameters of rehabilitation)(Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery)
研究者
Dae Wook Hwang
Assistant professor
Asan Medical Center