Procedure Selection in Obesity and Metabolic Surgery Based on EOSS

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Other: Role of EOSS

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.

• Study Type: Interventional
• Enrollment (Actual): 9437
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Offenbach am Main, Germany, 63069
    • Sana Klinikum Offenbach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RNYGB; The role of EOSS for the surgical intervention: Roux-en-Y gastric bypass for severe obesity	Other: Role of EOSS; 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.
Active Comparator: Sleeve; The role of EOSS for the surgical intervention: Sleeve Gastrectomy for severe obesity	Other: Role of EOSS; 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.
Active Comparator: MGB/OAGB; The role of EOSS for the surgical intervention: Mini/One anastomosis gastric bypass for severe obesity	Other: Role of EOSS; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sana Klinikum Offenbach
• Collaborators: Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie
• Investigators: Study Director: Rudolf Weiner, Prof., Sana Klinikum Offenbach

Publications and helpful links

General Publications

• Sharma AM, Kushner RF. A proposed clinical staging system for obesity. Int J Obes (Lond). 2009 Mar;33(3):289-95. doi: 10.1038/ijo.2009.2. Epub 2009 Feb 3.
• Kuk JL, Ardern CI, Church TS, Sharma AM, Padwal R, Sui X, Blair SN. Edmonton Obesity Staging System: association with weight history and mortality risk. Appl Physiol Nutr Metab. 2011 Aug;36(4):570-6. doi: 10.1139/h11-058. Epub 2011 Aug 14.
• Padwal RS, Pajewski NM, Allison DB, Sharma AM. Using the Edmonton obesity staging system to predict mortality in a population-representative cohort of people with overweight and obesity. CMAJ. 2011 Oct 4;183(14):E1059-66. doi: 10.1503/cmaj.110387. Epub 2011 Aug 15.
• Gill RS, Karmali S, Sharma AM. The potential role of the Edmonton obesity staging system in determining indications for bariatric surgery. Obes Surg. 2011 Dec;21(12):1947-9. doi: 10.1007/s11695-011-0533-8. No abstract available.
• Chiappetta S, Stier C, Squillante S, Theodoridou S, Weiner RA. The importance of the Edmonton Obesity Staging System in predicting postoperative outcome and 30-day mortality after metabolic surgery. Surg Obes Relat Dis. 2016 Dec;12(10):1847-1855. doi: 10.1016/j.soard.2016.02.042. Epub 2016 Mar 2.
• Chiappetta S, Stier C, Weiner RA; members of StuDoQ|MBE of Deutsche Gesellschaft fur Allgemein- und Viszeralchirurgie/StuDoQ. The Edmonton Obesity Staging System Predicts Perioperative Complications and Procedure Choice in Obesity and Metabolic Surgery-a German Nationwide Register-Based Cohort Study (StuDoQ|MBE). Obes Surg. 2019 Dec;29(12):3791-3799. doi: 10.1007/s11695-019-04015-y.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: EOSS; Obesity and metabolic surgery; postoperative outcome; procedure selection
• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Postoperative Complications
• Other Study ID Numbers: FF 83_2/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Anonymous data will be published in a peer-reviewed journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No