Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25,038
- 试验地点
- 1
- 主要终点
- Serious Complications
研究概览
简要总结
The rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. There are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. If the investigators are aware of these we can optimize the patients risk factors prior to the operation or at least increase the awareness of the increased risk in some patients given the presence of risk factors.
详细描述
Data is collected prospectively to the Scandinavian Obesity Surgery Registry. Today all 44 clinics performing bariatric surgery in Sweden submits data on baseline characteristics, operational data and data from a 30 days, 1 year, 2 years and 5 years follow up for all patients. The database is compared annually to the Swedish civil registry to cover all mortality.
From the database we will identify patients who underwent a bariatric procedure between May 1st 2007 and September 30th 2012. Patients undergoing other bariatric procedures than laparoscopic gastric bypass or revisional surgery will be excluded.
The data will be analyzed with "Chi-2" test, logarithmic regression, linear regression or t-test when appropriate. Odds ratio will be calculated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry
排除标准
- •Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded.
- •Lost to follow up.
结局指标
主要结局
Serious Complications
时间窗: 30 days or the postoperative hospital stay if longer than 30 days
Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)
次要结局
- Operating Time(operation)
- Length of Stay(30 days or the postoperative hospital stay if longer than 30 days)
- Specific Postoperative Complications(30 days or the postoperative hospital stay if longer than 30 days)
研究者
Erik Stenberg, MD
MD
Region Örebro County