Procedure Selection in Obesity and Metabolic Surgery Based on EOSS
- Conditions
- Postoperative Complications
- Interventions
- Other: Role of EOSS
- Registration Number
- NCT03556059
- Lead Sponsor
- Sana Klinikum Offenbach
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9437
Sleeve for severe obesity RNYGB for severe obesity MGB/OAGB for severe obesity
- previous obesity surgery
- previous surgery of the upper gastrointestinal tract in anamnesis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleeve Role of EOSS The role of EOSS for the surgical intervention: Sleeve Gastrectomy for severe obesity MGB/OAGB Role of EOSS The role of EOSS for the surgical intervention: Mini/One anastomosis gastric bypass for severe obesity RNYGB Role of EOSS The role of EOSS for the surgical intervention: Roux-en-Y gastric bypass for severe obesity
- Primary Outcome Measures
Name Time Method postoperative complications 30 days after surgery postoperative outcome after surgery next to the Clavien Dindo Classification
- Secondary Outcome Measures
Name Time Method postoperative complications related to surgical procedure 30 days after surgery postoperative complications related to surgical procedure
ASA related to Edmonton Obesity Staging System prior to surgery ASA related to Edmonton Obesity Staging System
Edmonton Obesity Staging System related to surgical procedure 30 days after surgery Edmonton Obesity Staging System related to surgical procedure
postoperative complications related to ASA 30 days after surgery postoperative complications related to ASA
Body Mass Index related to postoperative complications 30 days after surgery Body Mass Index related to postoperative complications
Edmonton Obesity Staging System related gender 30 days after surgery Edmonton Obesity Staging System related gender
postoperative complications related to Edmonton Obesity Staging System 30 days after surgery postoperative complications related to Edmonton Obesity Staging System
Edmonton Obesity Staging System related to length of postoperative stay 30 days after surgery Edmonton Obesity Staging System related to length of postoperative stay
postoperative complications related to gender 30 days after surgery postoperative complications related to gender
age related to postoperative complications 30 days after surgery age related to postoperative complications
Edmonton Obesity Staging System related to age 30 days after surgery Edmonton Obesity Staging System related to age
Edmonton Obesity Staging System related to readmission 30 days after surgery Edmonton Obesity Staging System related to readmission
Edmonton Obesity Staging System related to Body Mass Index 30 days after surgery Edmonton Obesity Staging System related to Body Mass Index
Trial Locations
- Locations (1)
Sana Klinikum Offenbach
🇩🇪Offenbach am Main, Germany