Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- 30 Days Perioperative Morbidity
研究概览
简要总结
The purpose of the study is to compare outcomes of laparoscopic versus open liver resection for colorectal metastases in a prospective and randomized study. The study will include all non-anatomic liver resections in our institution.
The primary end point is that the use of laparoscopic technique significantly can reduce the frequency of complications to liver resection. Secondary end points are 5-year survival, immediate surgical outcomes, quality of life and degree of impairment of the immune system.
详细描述
Full protocol is published open access in Trialsjournal:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for radical liver resection without formal liver resection or without assistance of radiofrequency ablation
排除标准
- •Inability to give written informed concent
- •Patients with tumors that can't be resected without reconstruction of vessels or bile ducts
- •Patients with tumors that can't be resected without 1)formal liver resection 2)combination with radiofrequency ablation
- •Patients with extrahepatic metastasis except resectable metastasis in lungs and adrenals
- •Pre- and peroperative diagnosis of non radically treatable disease
结局指标
主要结局
30 Days Perioperative Morbidity
时间窗: Within 30 days after surgery
This study aims to compare major intraoperative and postoperative parameters in patients randomized to either laparoscopic or open liver resection. Pre- and perioperative events relevant for surgical outcomes will be registered. The following intraoperative parameters will be compared: operative time, blood loss, blood transfusion, while intraoperative incidents will be classified according to the Satava classification. Morbidity within the first 30 days is the primary outcome (morbidity, yes/no), and will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al, by the Accordion system and by the Comprehensive Complication Index
次要结局
- 5 Year Survival(5 years after surgery)
- Recurrence Pattern(5 years)
- Postoperative Quality of Life(Up to 2 years)
- Health Economy(1 year)
- Molecular Biology(20 years)
- Severity of Morbidity(30 days)
- Number of Patients That Complete Adjuvant Oncologic Treatment(1 year)
- Immediate Oncologic Outcome(2 months after surgery)
- Readmissions(30 days)
- Incidence of Incisional Hernia(1 year)
- Surgical Trauma and Activation of the Immune System(72 hours)
- Severity of Postoperative Pain(4 months)
- Imaging(5 years)
- Anti-tumor Immunology(20 years)
- Level of Adhesions(2 years)
研究者
Åsmund Avdem Fretland
MD
Oslo University Hospital