Procedure Selection in Obesity and Metabolic Surgery Based on EOSS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Procedure Selection in Obesity and Metabolic Surgery Based on the Edmonton Obesity Staging System (EOSS) - a Nationwide German Register-based Cohort Study (StuDoQ MBE)

Conditions
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Postoperative Complications

Intervention / Treatment
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* Other: Role of EOSS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sleeve for severe obesity RNYGB for severe obesity MGB/OAGB for severe obesity - Exclusion Criteria: previous obesity surgery previous surgery of the upper gastrointestinal tract in anamnesis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A cohort of all patients who underwent obesity and metabolic surgery in Germany will be analyzed in relation to preoperative complications
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RNYGB<br>The role of EOSS for the surgical intervention: Roux-en-Y gastric bypass for severe obesity | Other: Role of EOSS<br>* The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than body mass index (BMI) or waist circumference. Its application for the selection of obese patients for obesity surgery has been suggested. This study evaluates the role of the Edmonton Obesity Staging System (EOSS) in predicting postoperative outcome (next to the Clavien Dindo Classification) and 30-day mortality after metabolic surgery.<br>|
| Active Comparator: Sleeve<br>The role of EOSS for the surgical intervention: Sleeve Gastrectomy for severe obesity | Other: Role of EOSS<br>* The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than body mass index (BMI) or waist circumference. Its application for the selection of obese patients for obesity surgery has been suggested. This study evaluates the role of the Edmonton Obesity Staging System (EOSS) in predicting postoperative outcome (next to the Clavien Dindo Classification) and 30-day mortality after metabolic surgery.<br>|
| Active Comparator: MGB/OAGB<br>The role of EOSS for the surgical intervention: Mini/One anastomosis gastric bypass for severe obesity | Other: Role of EOSS<br>* The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than body mass index (BMI) or waist circumference. Its application for the selection of obese patients for obesity surgery has been suggested. This study evaluates the role of the Edmonton Obesity Staging System (EOSS) in predicting postoperative outcome (next to the Clavien Dindo Classification) and 30-day mortality after metabolic surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | postoperative outcome after surgery next to the Clavien Dindo Classification | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications related to surgical procedure | postoperative complications related to surgical procedure | 30 days after surgery | 
| postoperative complications related to Edmonton Obesity Staging System | postoperative complications related to Edmonton Obesity Staging System | 30 days after surgery | 
| ASA related to Edmonton Obesity Staging System | ASA related to Edmonton Obesity Staging System | prior to surgery | 
| Edmonton Obesity Staging System related to length of postoperative stay | Edmonton Obesity Staging System related to length of postoperative stay | 30 days after surgery | 
| Edmonton Obesity Staging System related to readmission | Edmonton Obesity Staging System related to readmission | 30 days after surgery | 
| Edmonton Obesity Staging System related gender | Edmonton Obesity Staging System related gender | 30 days after surgery | 
| Edmonton Obesity Staging System related to surgical procedure | Edmonton Obesity Staging System related to surgical procedure | 30 days after surgery | 
| postoperative complications related to ASA | postoperative complications related to ASA | 30 days after surgery | 
| postoperative complications related to gender | postoperative complications related to gender | 30 days after surgery | 
| age related to postoperative complications | age related to postoperative complications | 30 days after surgery | 
| Body Mass Index related to postoperative complications | Body Mass Index related to postoperative complications | 30 days after surgery | 
| Edmonton Obesity Staging System related to age | Edmonton Obesity Staging System related to age | 30 days after surgery | 
| Edmonton Obesity Staging System related to Body Mass Index | Edmonton Obesity Staging System related to Body Mass Index | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EOSS, Obesity and metabolic surgery, postoperative outcome, procedure selection