Bariatric Surgery Benchmarks - How Much Do We Bench?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55,372
- 主要终点
- Number of participants with severe postoperative complications
研究概览
简要总结
The aim of this observational study is to define national reference values, according to the achievable benchmarks of care method (ABC™), for laparoscopic bariatric surgery in Sweden. The primary outcome is to identify the best possible, yet achievable, results during and after bariatric surgery. The second outcome to investigate if there are risk groups for complications, and if so perform risk-adjusted benchmark-calculations.
详细描述
The data source will be the Scandinavian Obesity Surgery Registry (SOReg), a prospective quality registry for obesity surgery. The time frame will be 2012-2021. The techniques to be investigated are laparoscopic roux-en-y gastric bypass and laparoscopic gastric sleeve respectively. Register variables related to surgical quality will be analyzed, and related to risk of peroperative and postoperative complications. The study will analyze data for the time of surgery and up to one year after surgery.
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
- •adults ≥ 18 years of age
- •primary laparoscopic gastric sleeve or primary laparoscopic roux-en-y gastric bypass
排除标准
- •other organ surgery at the time of the index operation
- •no data about surgery
- •no data about follow-up
结局指标
主要结局
Number of participants with severe postoperative complications
时间窗: Within 30 days and one year after surgery
Severe complication is defined as Clavien-Dindo grade ≥ IIIa
Benchmark values of variables related to surgical quality
时间窗: Surgical intervention and up to one year after surgery
ABC method of variables related to surgical quality (duration of surgery (minutes), complications (percentage), reoperations (percentage), weight loss at one year (percentage) etc)
次要结局
- Potential risk groups for complications(Within 30 days and one year after surgery)
- Risk-adjusted benchmark values(Within 30 days and one year after surgery)
研究者
Ebba Kihlstedt Pasquier
Principal Investigator
Region Östergötland