Benchmarks in Elective Laparoscopic Cholecystectomy - a National Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60,000
- 主要终点
- Benchmark values of elective laparoscopic cholecystectomy
研究概览
简要总结
The aim of this observational cohort study is to define peri- and postoperative reference values for elective laparoscopic cholecystectomy, using the achievable benchmarks of care methodology (ABC™). Another aim is to develop adjusted reference values for groups with a risk factor of severe postoperative complications. The over-arching aim is to inspire quality improvement initiatives.
详细描述
The data source is the Swedish patient registry GallRiks, a prospective quality registry for gallbladder surgery and endoscopic retrograde cholangio-pancreatography (ERCP). The time frame will be 2015-2023. Register variables related to surgical quality will be analyzed, such as postoperative complications, perioperative adverse events, surgical duration and length of stay. The study will analyze data for the time of surgery and up to 30 days afterwards. Since the data is not yet available to the researchers the number of enrolled study participants can not be specified with certitude; therefore an anticipated number is given.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •adults ≥ 18 years of age
- •laparoscopic primary cholecystectomy
排除标准
- •patients with current acute cholecystitis, pancreatitis or cholangitis
- •cholecystectomy due to malignancy
- •other organ surgery performed at the same occasion
- •previous upper gastrointestinal surgery
- •single port access
- •robotic surgery
- •no data concerning surgical intervention
结局指标
主要结局
Benchmark values of elective laparoscopic cholecystectomy
时间窗: Day of surgery
The study will use the ABC methodology to identify reference values of surgical duration (minutes), perioperative cholangiography, conversion to open surgery and adverse events
Postoperative benchmark values of elective laparoscopic cholecystectomy
时间窗: 0-30 days after surgery
The study will use the ABC methodology to identify reference values of the postoperative variables: hospital length of stay (days), abscess/infection, bleeding, biliary leakage, readmission, reoperation
次要结局
- Adjusted benchmarks for severe complications(0-30 days after surgery)
研究者
Ebba Kihlstedt Pasquier
Principal investigator
Region Östergötland