Physical Recovery After Laparoscopic vs. Open Liver Resection - a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Overall change in performance
研究概览
简要总结
The role of laparoscopic liver surgery with respect to clinical outcome remains unclear.
详细描述
The role of laparoscopic liver surgery with respect to clinical outcome remains unclear. The investigators hypothesized that laparoscopic liver resection (LLR) is associated with better postoperative recovery than open liver resection (OLR).
Twenty-one patients who underwent LR were included in this study (11 OLR (52.4%) and 10 LLR (47.6%), respectively). Postoperative recovery was measured by bicycle stress testing at months 1 and 6 after surgery and compared to preoperative stress testing. Standardized performance for bicycle stress testing was calculated based on age, sex, height and weight. Postoperative recovery was compared between groups as change of performance (%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all patients undergoing liver resection (open vs. laparoscopic)
- •all patients willing participate and gave written informed consent
排除标准
- •pregnancy
- •significant traumatic injury within 30 days prior to study enrolment
- •inability or unwillingness to comply to the protocol or to perform bicycle ergometry
研究组 & 干预措施
laparoscopic liver resection
Patients undergoing laparoscopic liver resection
干预措施: Ergometry (Other)
open liver resection
Patients undergoing open liver resection
干预措施: Ergometry (Other)
结局指标
主要结局
Overall change in performance
时间窗: 1, 6 months
The change in performance after 1 and 6 months postoperatively in comparison to preoperative ergometry.
次要结局
- Postoperative Complications(1 months)
- Liver resection and effect on postoperative fitness(2 years)
- length of stay(1 month)
研究者
Klaus Kaczirek
Clinical Professor
Medical University of Vienna