Clinical Trials Directory

Trials / Completed

CompletedNCT03556059

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
Phase
N/A
Study type
Interventional
Enrollment
9,437 (actual)
Sponsor
Sana Klinikum Offenbach · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERRole of EOSSThe 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.

Timeline

Start date
2015-02-01
Primary completion
2018-12-01
Completion
2018-12-01
First posted
2018-06-14
Last updated
2019-01-24

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03556059. Inclusion in this directory is not an endorsement.