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NCT02607267 Clinical Trial

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

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02607267
Other study ID # FF 83/2015
Secondary ID
Status Completed
Phase
First received November 16, 2015
Last updated April 24, 2018
Start date October 2014
Est. completion date January 2016

Study information
Verified date April 2018
Source Sana Klinikum Offenbach
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 534
Est. completion date January 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 19 Years to 73 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
Germany Sana Klinikum Offenbach Offenbach am Main Hessen

Sponsors (1)
Lead Sponsor Collaborator
Sana Klinikum Offenbach

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative outcome related to EOSS 30 days after surgery
Secondary postoperative complications related to EOSS 30 days after surgery
Secondary readmission rates related to EOSS 30 days after surgery
Secondary age related to postoperative complications 30 days after surgery
Secondary BMI related to postoperative complications 30 days after surgery
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