Procedure Selection in Obesity and Metabolic Surgery Based on the Edmonton Obesity Staging System (EOSS) - a Nationwide German Register-based Cohort Study (StuDoQ MBE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9,437
- 试验地点
- 1
- 主要终点
- postoperative complications
研究概览
简要总结
The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than BMI or waist circumference. EOSS is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery.
The aim of this study is to determine whether EOSS could be an indicator for procedure selection in obesity and metabolic surgery.
详细描述
All patients in Germany, who underwent Sleeve Gastrectomy, Roux-en Y Gastric Bypass and Mini/One anastomosis Gastric Bypass as a primary procedure for severe obesity, are prospectively registered in the German register StuDoQ MBE.
Preoperative EOSS by Sharma et al. will be applied to all patients, who were operated between Februar 2015 and July 2017 by two different evaluators. Data collection will include the following: gender, age, body mass index, mobility, comorbidities, ASA score (American Society of Anesthesiologists score) perioperative complications next to Clavien Dindo, readmission rates and 30 - day mortality. Follow-up will be investigated in all patients up to 1 month after surgery.
Complications, readmission rates and 30 day mortality will be investigated in relation to EOSS and the surgical procedure performed, to determine whether EOSS could be an indicator for procedure selection in obesity and metabolic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sleeve for severe obesity RNYGB for severe obesity MGB/OAGB for severe obesity
排除标准
- •previous obesity surgery
- •previous surgery of the upper gastrointestinal tract in anamnesis
研究组 & 干预措施
RNYGB
The role of EOSS for the surgical intervention: Roux-en-Y gastric bypass for severe obesity
干预措施: Role of EOSS (Other)
Sleeve
The role of EOSS for the surgical intervention: Sleeve Gastrectomy for severe obesity
干预措施: Role of EOSS (Other)
MGB/OAGB
The role of EOSS for the surgical intervention: Mini/One anastomosis gastric bypass for severe obesity
干预措施: Role of EOSS (Other)
结局指标
主要结局
postoperative complications
时间窗: 30 days after surgery
postoperative outcome after surgery next to the Clavien Dindo Classification
次要结局
- postoperative complications related to surgical procedure(30 days after surgery)
- ASA related to Edmonton Obesity Staging System(prior to surgery)
- Edmonton Obesity Staging System related to surgical procedure(30 days after surgery)
- postoperative complications related to ASA(30 days after surgery)
- Body Mass Index related to postoperative complications(30 days after surgery)
- Edmonton Obesity Staging System related gender(30 days after surgery)
- postoperative complications related to Edmonton Obesity Staging System(30 days after surgery)
- Edmonton Obesity Staging System related to length of postoperative stay(30 days after surgery)
- postoperative complications related to gender(30 days after surgery)
- age related to postoperative complications(30 days after surgery)
- Edmonton Obesity Staging System related to age(30 days after surgery)
- Edmonton Obesity Staging System related to readmission(30 days after surgery)
- Edmonton Obesity Staging System related to Body Mass Index(30 days after surgery)
研究者
Sonja Chiappetta, MD
Senior consultant, Principal Investigator, MD
Sana Klinikum Offenbach