NCT01768728已完成不适用
A Randomized Controlled Trial of Acute Surgical Trauma and Stress Response of Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Plasma C-reactive protein (CRP) level
研究概览
简要总结
The purpose of this study is to investigate the influence of the laparoscopic and open left hemihepatectomy on acute surgical trauma and stress response.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with benign lesions who requires left hemihepatectomy
- •Child-Pugh classification of A to B
- •American Society Of Anesthesiologists (ASA) grading of I to III
- •a body mass index of between 18 and 35
- •willingness to participate in the study
- •able to understand the nature of the study and what will be required of them
排除标准
- •pregnant or lactating women
- •unwillingness to participate
- •Child-Pugh classification of C
- •ASA grading of IV to V
- •with condition of acute inflammatory,fever or diabetes mellitus
- •with autoimmune disease or immunodeficiency
- •taking drugs that affect the immune system
研究组 & 干预措施
Laparoscopic left hemihepatectomy group
Active Comparator
Group of patients that are operated with laparoscopic left hemihepatectomy
干预措施: Laparoscopic left hemihepatectomy (Procedure)
Open left hemihepatectomy
Active Comparator
Group of patients operated with open left hemihepatectomy
干预措施: Open left hemihepatectomy (Procedure)
结局指标
主要结局
Plasma C-reactive protein (CRP) level
时间窗: up to 7 days
CRP will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
次要结局
- Inflammatory response markers including interleukin-6, interleukin-10 concentrations and tumor necrosis factor α level in serum(up to 7 days)
- Systemic inflammatory response syndrome(up to 7 days)
- Oxidative stress status including plasma malondialdehyde level and total antioxidant capacity(up to 7 days)
- Immune status including white blood cell count and human leukocyte antigen DR (HLA-DR) expression(up to 7 days)
- Status of insulin resistant(up to 7 days)
- Status of hepatic cell apoptosis including hematoxylin and eosin (HE) staining, immunohistochemistry staining and caspase-3 expression(24 hours)
- Time to functional recovery(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Postoperative hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 8 days)
- Morbidity and mortality(up to 1 month)
- Quality of life(up to 1 month)
- Intraoperative parameters including operation time, pneumoperitoneum time, liver resection time, intraoperative estimated blood loss,transfusion(participants will be followed for the duration of operation, an expected average of 120 minutes)
研究者
Xiujun Cai
Executive Vice-President
Sir Run Run Shaw Hospital
研究点 (1)
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