Edmonton Obesity Staging System: Post-operative Outcome and 30-day Mortality

April 24, 2018 updated by: Sonja Chiappetta, MD, Sana Klinikum Offenbach

The Importance of the Edmonton Obesity Score System in Predicting Postoperative Outcome and 30 Day Mortality After Metabolic Surgery

The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than BMI or waist circumference. The aim of this study is to determine whether the EOSS is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From October 2014 to December 2015 the investigators conducted a prospective data collection on patients undergoing either laparoscopic sleeve gastrectomy (LSG) or laparoscopic Gastric Bypass (Laparoscopic Roux-en-Y-Gastric Bypass (LRYGB) and Omega-Loop-Gastric-Bypass (LOLGB)), being the first surgical treatment for severe obesity. Preoperative EOSS by Sharma et al. was applied to all patients by two different evaluators. Data collection included the following: gender, age, body mass index, waist circumference, waist to hip ratio, comorbidities, early - postoperative complications, readmission rates and 30 - day mortality. Follow-up was performed in all patients up to 1 month after surgery.

Study Type

Observational

Enrollment (Actual)

534

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 73 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing either LSG, LRYGB or LOLGB, being the first surgical treatment for severe obesity

Description

Inclusion Criteria:

  • patients undergoing either LSG or LRYGB, being the first surgical treatment for severe obesity

Exclusion Criteria:

  • bariatric surgery in the anamnesis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
laparoscopic Roux en Y Gastric Bypass
patients undergoing LRYGB, being the first surgical treatment for severe obesity
Other: LSG and LRYGB
The role of the Edmonton Obesity Staging System in predicting post-operative outcome and 30-day mortality after metabolic surgery (LSG and LRYGB)
laparoscopic Sleeve Gastrectomy
patients undergoing LSG, being the first surgical treatment for severe obesity
Other: LSG and LRYGB
The role of the Edmonton Obesity Staging System in predicting post-operative outcome and 30-day mortality after metabolic surgery (LSG and LRYGB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative outcome related to EOSS
Time Frame: 30 days after surgery
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative complications related to EOSS
Time Frame: 30 days after surgery
30 days after surgery
readmission rates related to EOSS
Time Frame: 30 days after surgery
30 days after surgery
age related to postoperative complications
Time Frame: 30 days after surgery
30 days after surgery
BMI related to postoperative complications
Time Frame: 30 days after surgery
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sana Klinikum Offenbach

Investigators

  • Study Director: Christine Stier, MD, Sana Klinikum Offenbach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (ESTIMATE)

November 18, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF 83/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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