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

Completed

• Conditions: Other Complications of Other Bariatric Procedure; Postoperative Complications
• Interventions: Other: LSG and LRYGB

• Registration Number: NCT02607267
• Lead Sponsor: Sana Klinikum Offenbach

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. 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.

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-18
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

Inclusion Criteria

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

Exclusion Criteria

• bariatric surgery in the anamnesis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laparoscopic Sleeve Gastrectomy	LSG and LRYGB	patients undergoing LSG, being the first surgical treatment for severe obesity
laparoscopic Roux en Y Gastric Bypass	LSG and LRYGB	patients undergoing LRYGB, being the first surgical treatment for severe obesity

Primary Outcome Measures

Name	Time	Method
postoperative outcome related to EOSS	30 days after surgery

Secondary Outcome Measures

Name	Time	Method
postoperative complications related to EOSS	30 days after surgery
readmission rates related to EOSS	30 days after surgery
age related to postoperative complications	30 days after surgery
BMI related to postoperative complications	30 days after surgery

Trial Locations

Locations (1)

Sana Klinikum Offenbach; 🇩🇪 Offenbach am Main, Hessen, Germany