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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03556059
Enrollment
9437
Registered
2018-06-14
Start date
2015-02-28
Completion date
2018-12-31
Last updated
2019-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

EOSS, Obesity and metabolic surgery, postoperative outcome, procedure selection

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.

Interventions

OTHERRole 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.

Sponsors

Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie
CollaboratorOTHER
Sana Klinikum Offenbach
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

A cohort of all patients who underwent obesity and metabolic surgery in Germany will be analyzed in relation to preoperative complications

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative complications30 days after surgerypostoperative outcome after surgery next to the Clavien Dindo Classification

Secondary

MeasureTime frameDescription
postoperative complications related to Edmonton Obesity Staging System30 days after surgerypostoperative complications related to Edmonton Obesity Staging System
ASA related to Edmonton Obesity Staging Systemprior to surgeryASA related to Edmonton Obesity Staging System
Edmonton Obesity Staging System related to length of postoperative stay30 days after surgeryEdmonton Obesity Staging System related to length of postoperative stay
Edmonton Obesity Staging System related to readmission30 days after surgeryEdmonton Obesity Staging System related to readmission
Edmonton Obesity Staging System related gender30 days after surgeryEdmonton Obesity Staging System related gender
Edmonton Obesity Staging System related to surgical procedure30 days after surgeryEdmonton Obesity Staging System related to surgical procedure
postoperative complications related to surgical procedure30 days after surgerypostoperative complications related to surgical procedure
postoperative complications related to gender30 days after surgerypostoperative complications related to gender
age related to postoperative complications30 days after surgeryage related to postoperative complications
Body Mass Index related to postoperative complications30 days after surgeryBody Mass Index related to postoperative complications
Edmonton Obesity Staging System related to age30 days after surgeryEdmonton Obesity Staging System related to age
Edmonton Obesity Staging System related to Body Mass Index30 days after surgeryEdmonton Obesity Staging System related to Body Mass Index
postoperative complications related to ASA30 days after surgerypostoperative complications related to ASA

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026