Indications, Trends, and Perioperative Outcomes of Minimally Invasive and Open Liver Surgery in Non-obese and Obese Patients: an International Multicentre Propensity Score Matched Retrospective Cohort Study of 9963 Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9,963
- 试验地点
- 1
- 主要终点
- Major complications
研究概览
简要总结
Despite the worldwide increase of both obesity and use of minimally invasive liver surgery(MILS), evidence regarding the safety and eventual benefits of MILS in obese patients is scarce. The aim of this study is therefore to compare the outcomes of non-obese and obese patients(BMI 18.5-29.9 and BMI≥30, respectively) undergoing MILS and OLS, and to assess trends in MILS use among obese patients. In this retrospective cohort study, patients operated at 20 hospitals in eight countries(2009-2019) will be included and the characteristics and outcomes of non-obese and obese patients will be compared. Thereafter, the outcomes of MILS and OLS were compared in both groups after propensity-score matching(PSM). Changes in the adoption of MILS during the study period will be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 aged 18 years and older
- •Patients that have undergone an elective minimally invasive or open liver resection
排除标准
- •Patients that have undergone a hand-assisted or robotic procedure
- •Patients with a BMI lower than 18.5
结局指标
主要结局
Major complications
时间窗: 30 days postoperatively
Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure
次要结局
- R0 resection margin(30 days postoperatively)
- Conversion to open surgery(During the surgical procedure)
- Length of hospital stay(30 days postoperatively)
- Respiratory complications(30 days postoperatively)
- Wound-related complications(30 days postoperatively)
- Intraoperative blood loss(During the surgical procedure)
- Post-hepatectomy liver failure(30 days postoperatively)
- Mortality(90 days postoperatively)
- Overall complications(30 days postoperatively)
- Operative time(During the surgical procedure)
- Bile leak(30 days postoperatively)
- Ascites(30 days postoperatively)
- Red blood cell transfusion(During the surgical procedure)